GMP Audit Report

VERIQUALITY INSPECTION SERVICE

Report No.: xxxxxxxxxx

Doc No.: GMPC Version: 001 Page 1 of 35

Cosmetic GMP Audit

1. Details of the audit:

Stage Initial evaluation Pre-production evaluation Re-evaluation Products Salt of the Earth Deodorant Spray Participants xxxxxxxxxxx Factory xxxxxxxxxxx Details

2. Supplier typology:

Typology Details Name

Direct to factory Through third

party Agent Corporation Trading Other: Veriquality Inspection Service

3. Audit Results and final scoring:

Part Details Final Scoring Graphic Analysis 1.0 Quality System B 2.0 Purchasing B 3.0 Manufacturing C 4.0 Subcontracted Manufacturing N/AP 5.0 Quality Management C

Conclusion: C




Cosmetic GMP Audit Checkpoints

1.0. Quality System:

No

Checkpoint Score Comments and appreciation

1.1 Introduction

1.1.1 Does the Factory have a fully documented Quality System appropriate to its activities and to the nature of its products and backed by Senior Management?

B

1.1.2 At the manufacturing level, does the system encompass the organizational structure, responsibilities, available resources, procedures and processes involved in Quality Management.

B

1.1.3 Is the organizational structure clearly defined, in order to understand the organization and functioning of the Factory.

B

1.1.4 Does the Factory analyze irregularities and take corrective action as well as ensuring continuous improvement and adequate monitoring.

B

1.2 Staff

1.2.1 Do the personnel supervising or performing the manufacture or control of cosmetics have the education, training and/or experience to perform the assigned functions.

C 2009 Annual Training Records: Training records only have the training title, no included the content and personnel involved.

1.2.2 Are the training needs of all personnel at all levels within the Factory identified and the corresponding training plan in place and operational.

B

1.2.3 Is provision made for staff to cover absentees.

B

1.2.4 Do employees receive education in cosmetics GMP

B

1.2.5 Are there instructions for appropriate clothing for external workers (e.g. electricians) and visitors ?

B

1.2.6 Do fixed, written instructions regulate the hygiene? (washing and disinfecting hands)

B




1.3 Buildings

1.3.1 Are the buildings used in the manufacture or storage of cosmetics of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation and proper cleaning and maintenance.

B The garbage was burning in the surrounding area of the building during audit. The waste treatment is not according to operating instructions required.

1.0. Quality System: (Cont’d)

1.3 Buildings (Cont’d)

1.3.2 Are floors, walls and ceilings constructed of smooth, easily cleanable surfaces and kept clean and in good repair.

B

1.3.3 Are fixtures, ducts and pipes installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment or finished products in bulk.

A

1.3.4 Is the lighting and ventilation sufficient for the intended operation and comfort of personnel.

A

1.3.5 Is the water supply, washing and toilet facilities, floor drainage and sewage system adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

C 1）Toilet sink was not equipped with Dryers and papers. 2) Toilet (male) opened windows and screens.

1.3.6 Are the different manufacturing and storage areas designed to avoid unnecessary movement and cross flows.

B

1.3.7 Are there any hygiene zones and sluices ? B

1.4 Apparatus

1.4.1 Is equipment and utensils used in the processing, holding, transferring and filling of appropriate design, material and workmanship to prevent corrosion, buildup of material or adulteration with lubricants, dirt or sanitizing agents.

B

1.4.2 Are utensils, transfer pipe and cosmetic contact surfaces of equipment well maintained and clean and sanitized at appropriate intervals.

C There is no clear requirement regarding how to handle such kind of unexpected broken with glass bottle

1.4.3 Are all measuring instruments used in manufacturing and inspection appropriate, accurate and reliable.

B




1.4.4 Does Manufacturing equipment undergo regular upkeep and maintenance in accordance to pre-determined programs.

C Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December .

1.4.5 Is apparatus inspected before any manufacturing operation is started, in order to check that the machinery and instruments are in good condition. It should be appropriately cleaned and rinsed so as to avoid any product contamination.

B


1.4 Apparatus (Cont’d)

1.4.6 Are cleaned and sanitized portable equipment and utensils stored and located, and cosmetic contact surfaces of equipment covered, in a manner that protects them from splash, dust or other contamination.

B

1.4.7 Are machines clearly marked ? B 1.4.8 Are test laboratories adequate equipped ? B

1.5 Procedures & Processes

1.5.1 Does the Factory have its own procedures and instructions appropriate to its production and its organizational structure.

B

1.5.2 Are procedures and instructions properly written and established. They should describe the operations to be conducted, the precautions to be taken and the measures to be adopted in the different manufacturing stages.

C 1 ） Emulsification reaction workshop : The emergency indicator made by glass was found broken . The broken was not cleared out of the production area.

1.5.3 Do the procedures include all the processes used in the manufacturing cycle.

B

1.5.4 Are procedures established in particular for the following:

1.5.4.1 The sampling of raw materials and packaging materials.

B

1.5.4.2 The verification of manufacturing processes, packaging methods, inspection methods, equipment and installations.

B

1.5.4.3 The calibration of measuring instruments used during manufacturing and on packaging lines.

B

1.5.4.4 The cleaning and/or disinfection of premises and equipment used in manufacturing.

B




1.5.4.5 The activities to be conducted prior to beginning any manufacturing operation, for example: Line clearance.

C Emulsification reaction workshop : The previous production material was not cleared from the production area.

1.5.4.6 The product recall measures. A 1.5.4.7 The measures to be taken and procedures to

be followed as regards the conformity of packaging materials, raw materials, bulk products and finished products.

B

1.5.5 Do the Instructions for each product(s) describe in detail operations concerning the manufacturing process and packaging, the resources to be used and methods to be applied.

B


1.5 Procedures & Processes (Cont’d)

1.5.6 Are procedures and instructions readily accessible at all times to the staff who need to use

B

1.5.7 Is special provision made on staff safety and to the environmental impact of all activities, especially where waste management is concerned.

B

1.5.8 Processes

1.5.8.1 Are processes used in manufacturing, packaging, storage (of raw materials, bulk products and finished products), the maintenance of apparatus, buildings etc. clearly described.

B

1.5.8.2 Is provision made for the updating and control of all documents.

B

1.5.8.3 Are procedures and instructions adequately filed.

B

Conclusion: Part 1 Quality System B Total score A score B score C Score D Score Rating 41 3X3=9 32X1=32 0X6=0 0 1




2.0 Purchasing:

No


2.1 Contract Requirements Are procedures laid down stating the responsibilities for:

2.1.1 The establishment of specifications concerning raw materials, packaging materials, manufacturing apparatus and subcontracting.

B

2.1.2 The establishment of technical contract clauses (the type of inspection to be carried out, acceptance and rejection criteria, provisions in the event of non-conformity or modification).

B

2.1.3 Approval of Suppliers or Subcontractors (Quality and Quality Assurance): Purchase orders may be placed only for specified supplies from suppliers previously approved, preferably by the Manufacturer.

B

2.1.4 The establishment of the type of relations and exchanges between Customer / Supplier (assistance, audit), the prohibition of subcontracting without the Customer’s consent.

B

2.1.5 The inspection and testing on the premises of the supplier or subcontractor, and the audit of their Quality System.

B

2.2 Purchase Documents

2.2.1 Do the purchase documents contain data clearly describing the product.

B

2.2.2 Does the procedure clearly define the responsibilities as regards the formalization of the deed of purchase, the type of information necessary, requirements, quality references, the method of circulation and dissemination (internal or external) of orders placed.

B

Conclusion: Part 2 Purchasing B Total score A score B score C Score D Score Rating 7 0x3=0 7x1=7 0 0 1

3.0 Manufacturing:

No


3.1 Receipt of Incoming Goods




3.1.1 Are all items used for manufacturing accepted in accordance with established procedures and current safety regulations.

B

3.1.2 Is each delivery of items clearly recorded. B 3.1.3 Are the goods received checked for compliance

against the delivery slip, as should the condition of the packaging. If necessary a reservation made in respect of any faults founds. Are goods showing irregularities, which might affect product quality declared as awaiting decision.

B

3.1.4 Do records identify the incoming products and contain the following information:

B

3.1.4.1 The name of the product entered on the delivery slip and/ or packaging.

B

3.1.4.2 The name given to the product by the Factory if it is different from that of the Supplier and/or its code number.

B

3.1.4.3 Date of Receipt. B 3.1.4.4 Supplier’s Name. B 3.1.4.5 Batch Reference(s). B 3.1.4.6 Total quantity delivered and number of

packages received. B

3.1.5 For materials received in bulk, are special precautions taken in order to avoid any contamination and or/ deterioration.

C In coming Material Storage: Many barrels of raw materials did not cover the lid.

3.1.6 Does the type of verification performed on receipt of purchased products depend on the approval of the Supplier/Subcontractor’s verification system and the performance capabilities of his/her Quality System.

B

3.1.7 Does the internal identification and storage of products after delivery follow established procedures.

B

3.2 Water

3.2.1 Water production and supply systems should provide at all times water of a quality, which will guarantee the conformity of the manufactured products.

B

3.0 Manufacturing:(Cont’d)

3.2 Water (Cont’d)

3.2.2 Are the water supply systems able to be disinfected in accordance with established procedures.

B

3.2.3 Are pipes designed to avoid stagnation and risks of contamination.

B

3.2.4 Are the materials used selected to ensure that the quality of the water will not be affected.

B

3.2.5 Are there suitable markings to identify the pipes carrying water for manufacturing purposes (hot, cold, demineralized), cleaning water, cooling

B




water, steam and others. 3.2.6 Is the chemical and microbiological quality of

the water regularly tested in accordance with written procedures, and any deviation from specifications followed up by corrective action.

C The third party test report for purified water was not available . The factory claimed that they would send purified water to the third party each month for test . The test report was not retained .

3.3 Warehousing & Storage

3.3.1 Are procedures in place for the storage of incoming products.

B

3.3.2 Are materials required for manufacturing stored in premises kept clean and tidy and in accordance with current safety regulations.

C Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items.

3.3.3 Are storage conditions suitable to each type of component.

B

3.3.4 Are entry/exit channels clearly distinguished. B 3.3.5 Does the storage facilitate the location of

batches. B

3.3.6 Is there a system installed to prevent any material from being used for manufacturing without having been first released.

B

3.3.7 Is there registration and periodic inventory checks to ensure the reliability of stock

B

3.3.8 Does the stock management ensure rational product turnover, e.g. through use of the FIFO System (First-in/First-out).

B

3.3.9 If raw materials or packaging materials remain unused after manufacturing and are to be returned to stock, is their designation, batch number and quantity clearly indicated as well as being re-entered into the stock management system.

B

3.3.10 Are all types of packaging closed and clean. Do they carry the same special utilization and/or safety instructions as at origin.

C In coming Material Storage: Many barrels of raw materials did not cover the lid.

3.3.11 Are reference samples stored of raw materials, bulk and finished products under prescribed conditions ? If yes for how long ?

B

3.3.12 Is the status of checked raw materials, bulk and finished products clearly labeled (labels on container) ?

C 1) Incoming Material Storage: one pallet of barrels without making any identification.

2) Product ID: All products or materials not specifically identified as acceptable goods or defective goods.

3) Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items.

4) Incoming Material Warehouse: the region identified as defective are actually racked the qualified product.





No


3.4 Manufacturing Process

3.4.1 Preparation

3.4.1.1 Are all raw materials used identified and quantified in accordance with the formula.

B

3.4.1.2 Are the raw materials listed in the formula measured or weighed:

B

3.4.1.2.1 Either in clean, suitable containers labeled with any necessary information, e.g. identification and safety requirements.

B

3.4.1.2.2 Or directly in the apparatus used for the manufacturing process.

B

3.4.2 Are raw materials handled so as to avoid contamination.

B

3.4.3 If packaging has been opened, has it been properly closed and restored to stock in conditions avoiding any risk of impairment of its content and be re-entered into the stock management system

B

3.5 Actual Manufacturing Process

3.5.1 Prior to any manufacturing process, do they ensure that:

3.5.1.1 All the necessary raw materials are available.

B

3.5.1.2 All documents required for manufacturing process are available (operational mode).

B

3.5.1.3 The necessary equipment is in good working order.

B

3.5.1.4 All apparatus is clean and if necessary disinfected.

B

3.5.1.5 Everything used for manufacturing different bulk products has been eliminated after each manufacturing process (raw materials, procedures etc.), if not required for the new manufacturing process.

C 1)Emulsification reaction workshop : The previous production material was not cleared from the production area.

3.5.2 Are all manufacturing processes carried out in accordance with the formula and detailed instructions specifying:

B

3.5.2.1 The necessary apparatus. B 3.5.2.2 The formula concerned and the precise

designation of the product. B





3.5 Actual Manufacturing Process (Cont’d)

3.5.2.3 The raw materials listed as designated in accordance with the regulations drawn up by the Factory, indicating the batch numbers and quantities measured.

B

3.5.2.4 The detailed manufacturing process for each stage: for example, the introduction sequences, temperatures, speeds, mixing times, sampling and verifications during or on completion of the manufacturing process, the protocol on the cleaning of equipment, as well as the requirements governing the transfer of bulk products.

B

3.5.3 Is it possible at all times to identify the product being manufactured by its designation and batch number.

B

3.6 Storage of Bulk Products

3.6.1 In the event of storage of bulk products awaiting packaging, do the procedures state:

3.6.1.1 The quality of the equipment.

B

3.6.1.2 The storage conditions. B 3.6.1.3 The tests carried out in the event of prolonged

storage. B

3.7 Packaging

3.7.1 Before any packaging operation, is the apparatus inspected for conformity.

B

3.7.2 Are all components required for packaging properly identified.

B

3.7.3 Are the necessary precautions taken to ensure proper line clearance (packaging materials and bulk products).

C 1) Packaging Workshop: a barrelhead was found at the underground of machine which full of dust. 2) Packaging Workshop: 2 barrels of the production samples were not removed without making any identifications

3.7.4 Is the designation of a product to be packaged indicated on the line or at the point of packaging.

B

3.8 Storage of Finished Products

3.8.1 Are operations concerning the storage and dispatch of finished products described in procedures indicating in particular the conditions required for maintenance of their quality.

B


3.8 Storage of Finished Products (Cont’d)

3.8.2 Before marketing, has the conformity of all B




finished products been accepted in accordance with established, efficient and regularly updated procedures.

3.8.3 Are measures taken to guarantee quality of conformity after final inspection and to ensure turnover of the stock.

B

Conclusion: Part 3 Manufacturing C Total score A score B score C Score D Score Rating 51 0X3=0 1X51=51 0X7=0 0 0.879




4.0 Subcontracted Manufacturing:

No


4.1 Are all subcontracted operations properly specified so as to conform to the product quality specification.

N/AP

4.2 Has the Contractor and Subcontractor drawn up a preliminary agreement and a specification book stating the conditions required for manufacturing of the product concerned, and outline their respective responsibilities.

N/AP

4.3 Are the responsibilities defined in the contract binding the two parties:

N/AP

4.3.1 Does the Contractor evaluate the Subcontractor’s ability to fulfill the contract and ascertain that the Subcontractor has the necessary buildings, apparatus, personnel etc.

N/AP

4.3.2 Does the Contractor provide the Subcontractor with all information required for manufacturing.

N/AP

4.3.3 Does the Subcontractor comply with the procedures set out in the specification book.

N/AP

4.3.4 Does the Subcontractor facilitate inspection and audit as requested by the Contractor or as agreed to in the specification book.

N/AP

Conclusion: Part 4 Subcontracted Manufacturing N/A Total score A score B score C Score D Score Rating




5.0 Quality Management:

No


5.1 Introduction

5.1.1 Does the Quality Management cover all the functions of the company.

B

5.1.2 Has the manufacturing department adopted and observe written procedures and instructions.

B

5.1.3 Does the Manufacturing staff participate in the preparation and drafting of procedures and instructions.

B

5.2 Quality Control

5.2.1 Are the results of inspections and the representative samples of batches of raw materials, packaging materials, bulk products and finished products which have been inspected, recorded and properly stored.

B

5.2.1.1 Do Control Laboratories assist the manufacturing department through:

B

5.2.1.2 Optimization of the manufacturing processes. B 5.2.1.3 Analysis of manufacturing problems. B 5.2.1.4 Participation of quality audits. B 5.2.2 Are all inspection conducted in accordance with

written procedures. B

5.3 Apparatus and Solvents

5.3.1 Are Installations, apparatus and reagents properly inspected and/or tested.

B

5.3.2 Do Control procedures apply to: 5.3.2.1 Premises: Cleaning, ventilation, lighting, heating

etc. B

5.3.2.2 Apparatus: Electrical equipment, pumps, pipes, washers, water purifying systems etc.

B

5.3.1.3 Processes: Manufacturing, packaging etc. B 5.3.1.4 Measuring instruments: Are these periodically

calibrated and maintained in good working order.

C Incoming Material Storage: one electronic balance missed the calibration identification .

5.3.3 Are regular inspections of the calibration carried out to confirm the accuracy of measurements displayed or recorded.

B

5.0 Quality Management: (Cont’d)

5.3 Apparatus and Solvents (Cont’d)

5.3.4 Are Measuring instruments found nonconforming clearly identified as being out of order.

B




5.3.5 Do Calibration procedures define: 5.3.5.1 The name of the apparatus. B 5.3.5.2 Its reference number if necessary. B 5.3.5.3 The calibration instructions. B 5.3.5.4 The calibration frequency and tolerance range. B 5.3.5.5 The measures to be taken if the calibration

tolerances are exceeded. B

5.3.6 Is each piece of apparatus to be calibrated carrying a label stating:

B

5.3.6.1 The date of the last calibration. B 5.3.6.2 The initials of the person who conducted the

calibration. B

5.3.6.3 The date of the next calibration. B 5.3.6.4 If any apparatus exceeds the tolerances, is it

clearly identified as such. B

5.3.6.5 Is each modification made on the apparatus properly recorded.

B

5.3.6.6 If necessary after modification, is the apparatus re-calibrated.

B

5.3.7 Do Reagents and solutions carry a label stating B 5.3.7.1 The name of the product. B 5.3.7.2 Its strength or degree of concentration. B 5.3.7.3 Its expiration date. B 5.3.7.4 The initials of the person who prepared it. B 5.3.8 Are written instructions for inspection available

in the Laboratory. B


No


5.4 Control Activities (Activities conducted by Control Laboratories and manufacturing Staff in order to supervise quality during manufacturing)

5.4.1 Does the Laboratory and Manufacturing staff have the following information available:

5.4.1.1 The specifications. B 5.4.1.2 Sampling Procedures. B 5.4.1.3 Inspection Methods. B 5.4.1.4 Established limit values. B 5.4.1.5 Instructions for the use of the Control

Laboratories. B

5.4.1.6 Procedures for calibration and maintenance of the control instruments.

B

5.4.1.7 Instructions for monitoring of the quality during manufacturing.

B




5.4.2 Do the specifications contain:

5.4.2.1 The internal code number or designation adopted by the Factory.

B

5.4.2.2 The qualitative and quantitative characteristics, with their established limit values.

B

5.4.2.3 Frequency of re-inspection as appropriate. B 5.4.2.4 Reference(s) to the methods to be used for

required determination. B

5.4.2.5 Special sampling instructions. B 5.4.3 How does the Factory determine the following: B

5.4.3.1 Conformity: Acceptance. B 5.4.3.2 Major Non-conformity: Rejection. B 5.4.3.3 Minor Non-conformity: In the case where non-

conformity will not influence the quality of the finished product, the batch may be accepted on an exceptional basis. This should be noted in the documents relating to the batch. Acceptable criteria for noon-conformity which are acceptable should be agreed with the client beforehand !

B

5.4.4 Are the persons entitled to grant authorization for use identified.

B


5.4 Control Activities (Cont’d)

5.4.5 Is each incoming batch of raw materials or packaging materials subject on arrival of either a simple identification check or a complete inspection.

B

5.4.6 Is conformity verified by internal controls or on the basis of a certificate of analysis.

B

5.4.7 Is the quality of the raw materials, packaging materials and bulk products checked at appropriate intervals to ensure that no deterioration has taken place.

B

5.5 Control Records

5.5.1 Do the control records include at least the following information:

5.5.1.1 Designation (internal code number, trade name etc.)

B

5.5.1.2 The batch number and date. B 5.5.1.3 The references to the specifications and

inspection methods. B

5.5.1.4 The results of all inspections, measurements or verifications performed, the initials, and the observations of the persons having carried them out.

B

5.5.1.5 In the case of acceptance testing, the decision to accept or reject should be stated very clearly.

B




5.6 Sampling and Sample Library

5.6.1 Are samples taken regularly in accordance with written procedures specifying:

B

5.6.1.1 The person(s) authorized to take samples. B 5.6.1.2 The quantities to be taken. B 5.6.1.3 The equipment to be used. B 5.6.1.4 The special precautions to be taken, in

particular when sampling microbiologically vulnerable materials.

B

5.6.1.5 Special sampling conditions (e.g. homogenization).

B

5.6.2 Is each sample sent to the Control Laboratory clearly identified by a label stating:

B

5.6.2.1 The name of the material or product. B





5.6 Sampling and Sample Library (Cont’d)

5.6.2.2 The batch number; where an internal batch number is given to an incoming product, traceability with the Supplier’s batch should be ensured.

B

5.6.2.3 The date of sampling. B 5.6.2.4 The initials of the person who took the samples. B 5.6.3 Are samples of each batch stored in a suitable

area (sample library) with access limited to those persons authorized to perform repeat controls.

B

5.6.4 Does the sample size allow for the complete analysis of two samples.

B

5.6.5 Are analysis records stored in accordance with company policy.

B

5.6.6 Is data from analysis of raw materials and packaging kept for a period of not less than one year.

B

5.6.7 Data for samples of finished products should be kept for a period equal to at least one half of the shelf-life.

B

5.7 Monitoring and Use of Data

5.7.1 Does the Factory analyze all data, particularly: 5.7.1.1 Measuring quality levels during manufacturing. B 5.7.1.2 Using this information in evaluating corrective

actions to be taken, based on the cause of observed defects.

B

5.7.1.3 Are the results of corrective actions monitored. B 5.7.2 Is this information compiled into a document. B 5.8 Control of Documents

5.8.1 Follow-up Documents

5.8.1.1 For each batch, records should be written concurrent with the action taken and include the following:

B

5.8.1.1.1 The measurements and verifications carried out during manufacturing and packaging.

B

5.8.1.1.2 The records from automated manufacturing installations and from control apparatus.

B





5.8.1 Follow-up Documents (Cont’d) 5.8.1.1.3 The remarks and observations of the

processing and packaging personnel during the manufacturing operations, including any manufacturing incidents.

B

5.8.1.2 Is there a link between the different manufacturing documents to allow for traceability.

B

5.8.2 Document Management

5.8.2.1 Are all documents regularly updated. C 1)Document Management: All the manuals, and procedure files from the release date were not updated and revised. Management representative has resigned in July,2009.But the previous management representative still listed at the quality manual. Management representative is currently vacant. 2) The Quality manual only showed the quality objective of 2008. The 2009 quality objective was not available.

5.8.2.2 Are all out-of-date documents immediately withdrawn to avoid their use.

B

5.8.2.2.1 Is the inventory of documents kept up-to-date. B 5.8.2.2.2 Is the Document Management based on a

procedure defining in particular: B

5.8.2.2.3 The person(s) who draw up and endorse the documents before dissemination.

B

5.8.2.2.4 The person(s) to whom the documents will be addressed.

B

5.8.2.2.5 The location and method of filing. B 5.8.2.2 For all modifications, is the following information

should be given: B

5.8.2.2.1 The nature of the changes. B 5.8.2.2.2 The person(s) responsible for the changes. B 5.8.2.2.3 The reason for the changes. B 5.8.2.2.4 The revision number and date of application. B

5.9 Management of Products Not in Conformity

5.9.1 In order to manage non-conforming products and to ensure corrective and/ or remedial action is taken, is there a system set up and documented in a written procedure.

B

5.9.2 Does the procedure address both irregularities noted during manufacturing as well as customer complaints.

B

5.9.3 Does the system ensure that all cases of non-conformity are dealt with so as to prevent recurrence.

B





5.10 Hygiene

5.10.1 Factory Hygiene 5.10.1.1 Doe the premises provide an adequate number

of toilets and washbasins. C The facet installed in the hand –washing basin for

Emulsification reaction workshop was found the no water out. And no alcohol inside the alcoholic bottle. However, the work instructions require hand-washing and disinfection with 75% alcohol.

5.10.1.2 Are these designed for easy cleaning and disinfection.

C The garbage was burning in the surrounding area of the building during audit. The waste treatment is not according to operating instructions required.

5.10.1.3 Is Apparatus accessible for cleaning and disinfection.

C 1(Filling Workshop C line: a large number glue of transparent plastic was stuck on the metal surface of the machine was not removed. 2) Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December . 3) SOP of cleaning & sterilization provide limited details against different component including plastic and glass bottle.

5.10.1.4 Are provisions made to prevent infestation by parasites, insects, rodents, birds etc.

C 1)Pest control records was ended in June. The records for afterwards month was not available. However, the work instruction required each month to conduct the contractual insecticidal activity. 2) Pest Control sub-contract expired in 2009-10-13. Factory did not renew the contract with the sub-contractor.

5.10.1.5 Are routine inspections carried out to detect their presence.

C 1）Aging room: a large number of fluid was leaked on the ground during audit.

5.10.1.6 Are written procedures describing cleaning and disinfection techniques followed in all stages of manufacturing.

C The detailed written procedure for cleaning & sterilization clothes and towels not available .But the daily cleaning & sterilization record was retained.

5.10.2 Hygiene of Personnel 5.10.2.1 Do person(s) coming into direct contact with

cosmetic materials, finished products in bulk or cosmetic surfaces, to the extent necessary to prevent adulteration of cosmetic products observe the following:, , gloves, hair restraints etc., and maintain adequate personal cleanliness:

C 1) Packaging Workshop and filling workshop: The daily cleaning & sterilization record of clothes, towels, was not available from October to December.

5.10.2.1.1 Wear clean, suitable clothing. C 1)Filling workshop: The clothes was hanging in the filling workshop during audit.

5.10.2.1.2 Wear gloves. B 5.10.2.1.3 Wear hair restraints / beard snoods. B 5.10.2.1.4 Jewelry should be removed, no rings, earrings,

necklaces, bracelets & watches. C The factory claimed that the factory have conducted

the foreign body contamination control such as




wearing control .But the written procedure was not available.

5.10.3 Are all cases of illness or injury, which could influence production reported so that measures can be taken to ensure that product quality is not affected.

C One health certificate was expired .The issuing date was 2008-04-14.The expired date was 2009-04-13.

5.10.4 Is eating, drinking and smoking permitted only in suitable designated areas separate from the manufacturing areas.

B

5.11 Audits

5.11.1 Are audits conducted independently and in depth, regularly or on requested, by competent person(s) appointed for the purpose.

C The factory provided vendor evaluation records . But the finance staff involved the evaluation, which was incompatible with her duties.





5.11 Audits (Cont’d)

5.11.2 Are audits conducted on the site of manufacturing or on the premises of the Subcontractor(s) and component Supplier(s).

B

5.11.3 Do audits concentrate on the Quality System in general。

B

5.11.4 Are the audit results forwarded to the Senior Management and communicated to staff members concerned, so that improvements can be implemented.

B

5.11.5 Is a check carried out to ensure that the improvements are in fact carried out.

B

Conclusion: Part 5 Quality Management C Total score A score B score C Score D Score Rating 104 0X3=0 1X104=104 0X11=0 0 0.904




6.0 Corrective actions requested to the factory:

No

Priority Details

1. Required (3 months) / 2. Advised / 3. Suggested 6.1 1 The garbage was burning in the surrounding area of the building

during audit. The waste treatment is not according to operating instructions required.

6.2 1 2009 Annual Training Records: Training records only have the training title, no included the content and personnel involved

6.3 1 Supplier Assessment: The factory provided vendor evaluation records . But the finance staff involved the evaluation, which was incompatible with her duties.

6.4 1 Document Management: All the manuals, and procedure files from the release date were not updated and revised. Management representative has resigned in July,2009.But the previous management representative still listed at the quality manual. Management representative is currently vacant.

6.5 1 The Quality manual only showed the quality objective of 2008. The 2009 quality objective was not available.

6.6 1 Pest control records was ended in June. The records for afterwards month was not available. However, the work instruction required each month to conduct the contractual insecticidal activity.

6.7 1 Pest Control sub-contract expired in 2009-10-13. Factory did not renew the contract with the sub-contractor.

6.8 1 Emulsification reaction workshop : The previous production material was not cleared from the production area.

6.9 1 Emulsification reaction workshop : The emergency indicator made by glass was found broken . The broken was not cleared out of the production area.

6.10 1 The facet installed in the hand –washing basin for Emulsification reaction workshop was found the no water out. And no alcohol inside the alcoholic bottle. However, the work Instructions require hand-washing and disinfection with 75% alcohol.

6.11 1 Product ID: All products not specifically identified as acceptable goods or defective goods.




6.12 1 Incoming Material Warehouse: the region identified as defective are actually racked the qualified product.

6.13 1 Incoming Material Warehouse: the area marked as broken glass processing area is indeed stored the other items.

6.14 1 Incoming Material Storage: one pallet of barrels without making any identification.

6.15 1 Incoming Material Storage: one electronic balance missed the calibration identification ..

6.16 1 In coming Material Storage: Many barrels of raw materials did not cover the lid.

6.17 1 Filling workshop: The clothes was hanging in the filling workshop during audit.

6.18 1 Aging room: a large number of fluid was leaked on the ground during audit.

6.19 1 Filling Workshop C line: a large number glue of transparent plastic was stuck on the metal surface of the machine was not removed.

6.20 1 Packaging Workshop: a barrelhead was found at the underground of machine which full of dust.

6.21 1 Packaging Workshop: 2 barrels of the production samples were not removed without making any identifications

6.22 1 Packaging Workshop and filling workshop: The daily cleaning & sterilization and maintenance record for machine and facility was not available from October to December .

6.23 1 Packaging Workshop and filling workshop: The daily cleaning & sterilization record of clothes, towels, was not available from October to December .

6.25 1 Toilet sink was not equipped with Dryers and papers.

6.26 1 Toilet (male) opened windows and screens.

6.27 1 There is no clear requirement regarding how to handle such kind of unexpected broken with glass bottle

6.28 1 The factory claimed that the factory have conducted the foreign body contamination control such as wearing control .But the written procedure was not available.

6.29 1 SOP of cleaning & sterilization provide limited details against different component including plastic and glass bottle.




6.30 1 The third party test report for purified water was not available . The factory claimed that they would send purified water to the third party each month for test . The test report was not retained .

6.31 1 The detailed written procedure for cleaning & sterilization clothes and towels not available .But the daily cleaning & sterilization record was retained.

6.32 1 One health certificate was expired .The issuing date was 2008-04-14.The expired date was 2009-04-13.

6.1 Additional comments and follow-up actions on Client’s side:

No

Details

6.1.1 During the audit , the factory was not under production . 6.1.2 6.1.3

6.2 Enclosures:




PHOTO ATTACHMENT

1 the business license 2 Tax Registration Certificate

3 Health License 4 Industrial Commodities Production Permit

5 Organizational code 6 GMPC certificate




7 operator health certificate 8 the health certificate was expired

9 pest control drawing 10 garbage burning

11 factory office 1 12 factory office 2




13 the door to workshop 14 the aisle of workshop

15 the aisle of workshop 2 16 the personnel storage

17 the shoe rack 18 the hand washing basin




19 the dryer 20 the washing instructor

21 the Emulsification reaction workshop4 22 Emulsification reaction workshop1

23 Emulsification reaction workshop 2 24 Emulsification reaction workshop3




25 the previous production material 26 the identification was not eligible

27 the broken glass at Emulsification reaction workshop1 28 the work instruction at the workplace

29 the defects area placed the qualified incoming material

30 broken glass processing area




31 barrels without making any identification. 32 barrel not cover the lid

33 missing the calibration identification sticker 34 barrel not cover the lid 2

35 malfunction of The facet 36 filling workshop 1




37 filling workshop 2 38 hygrothermograph

39 the clothing hanging at the filling workshop 40 the aging room

41 the filling room 42 the leaked liquid in the aging room




43 the semi-product in the aging room 44 glue of transparent plastic at the machine

45 without the identification at packing workshop 46 the cover full of dust

47 the product without identification at packing area 48 annual maintenance plan




49 the machine and facility daily maintenance record 50 the toilet without the dryer and paper

51 the window was open 52 pure water facility

53 pure water facility 2 54 the pure water quality test report




55 the pure water quality test report 2 56 the pure water test data record

57 Environmental Indicators Test Report 58 Clean area suspended particulates test report

59 draw sample and retain sample work instruction 60 Microbiology Test Report of Production area




61 the original record of microbiology test

End of the report