Upload
helmy-ismail
View
239
Download
3
Embed Size (px)
Citation preview
Level 2 Audit Report
GMS Quality - Audit Report
03/09
for
GSK QMS Audit of
Soft Gelatin& Wets Value stream
Date of Inspection:23-26 March 2009
Auditee Details Lead Auditor Details
Site
Location
GlaxoSmithKline Egypt
P.O. Box 3001-El Salam
City 11491 Cairo – Egypt
Lead
Auditor
Helmy Ismail
Compliance auditor
E-mail: [email protected]
Tel : +2 02 22777126
Main
Contact
Dr:Elhamy Kamal
Report Distribution
Complete Report
Eng.Adel Darwish Site director
Dr:Hanan Lamei Head of Quality
Dr: Eman Hegazy Compliance manager
Dr:Elhamy KamalWets &Cephs SLT
Eng. Khaled Gheith Engineering SLT
Dr.Sahar Awwad Technical senior manager & OE Champion
Mrs.Aya Dwidar Head of HR &Security
Dr. Abdelmoneim A
AbuYoussef
Solid SLT
1
Executive Audit Report Summary
Conclusion
1.1 Summary and Comments
The QMS implementation system in Soft gelatin department is in place and in use, the manufacturing
and packaging areas look tidy with good housekeeping. Three risks identified in the risk log {(SG04)
Liability of cross contamination in SG area, (SG 05) Medicine contamination and (SG08) Failure of the
pressure difference in SG area were disclosed and managed.
-The L4 CAPAs for Ukraine and MOH were closed effectively on time. The previous L2 audit findings
related to the above mentioned departments were reviewed and closed effectively.
During this audit there were 7 finding 3 of them were considered to be major.
The major findings related to The Facility operation, Air quality and Calibration.
The risk associated with the major findings as follows:
1-Deterioration in utilities maintenance that increases the possibilities of particulate cross contamination.
Inadequate physical contamination control due to presence of particulate shedding material in the
manufacturing area. Incomplete check of the cleaning record to ensure the effectiveness of the
cleaning procedure.
2- Lack of assurance that air of correct particulate quality is supplied to SG manufacturing area to
protect product from environmental contamination.
3- There is no document highlighting the product quality impact in case of instrument calibration failure
or instrument defect.
In conclusion:
According to the L2 local procedure and the criticality of area:
-The overall risk of soft Gelatin department is a moderate risk and it is recommended to keep the audit
frequency to be every 9 months.
-The overall risk of wets area is a high risk and it is recommended keeping the audit frequency to be
every 6 months to ensure the complete and effective closure of the raised risk.
1.2 Recommendation of Audit Frequency
Current Audit Frequency:
6 months
Decrease to
Remain
Audit Frequency:
9 months for SG
6 months for wets
Background information
2.1 Pharmaceutical Product Dosage Forms
2
Sterile Products Inhaled Products Other Dosage Form √
2.2 Markets Supplied
US √ EU JP AU CN Other:
2.3 Date of Last Audit
August 2008
* * * * * End of Executive Summary * * * * *
3
Audit Background
Introduction:
GSK Cairo is aiming to implement Quality Management System as
standard for internal audit level 2 for all systems.
The previous L2 audit conducted on August 08 , Based on the overall
risk assessment of the auditee profile . The Soft gelatin was considered
as a moderate risk and the Wets department was considered as a high
risk ,according to the number of rejected batches ,rework due to quality
issues ,numbers of complaints received during 2008 and the number of
major findings of the previous audit levels.
Objective:
The audit was to evaluate the level of compliance of systems compliance against QMS policies in respect to risk assessments, identified gaps and areas for improvement highlighted through the last GQA as well as the last L2 audit .
Scope:
The audit primarily focused on the activities and systems involved in the Soft gelatin, wets and semisolid including manufacturing and packaging at Cairo site facility. The audit also assessed the identification and management of risk and the effectiveness of total disclosure of the previous audit findings.
Audit team:
Salwa Tolba Compliance auditor
Auditee:
Dr:Mohab Elmasry Soft gelatin section head
Dr: Ahmed Samir Wets departmental head
Dr: Dalia Samy Senior validation coordinator
Dr:Ahmed Abdel Raouf Validation section head
4
Classification of Audit Findings
5
Audit Findings Classifications
Dependent on the nature of the findings and the risk associated with any non-
compliance the following classifications should be used:
Classification Description of Classification Action to be Taken
Critical Deficiencies which have a high
probability of causing adverse
consequences to the patient or
consumer; may result in
significant deviations in the safety,
identity, strength or purity of the
product; or are a combination of
major deficiencies which indicates
a critical system failure.
The auditor is to define which
operations, or supply to GSK,
must stop until corrective and
preventive actions (CAPAs) are
implemented.
Major Deficiencies which could
potentially cause adverse
consequences to the patient or
consumer if left un-addressed,
could be considered indicative of
poor control, could be considered
major deviations by regulatory
authorities, or a combination of
minor deficiencies which indicate
a major systems failure, or a
number of repetitive minor
deficiencies.
CAPAs are to be agreed although
operations can proceed.
Minor A deficiency which cannot be
classified as critical or major.
CAPAs are to be agreed although
operations can proceed.
Note A deficiency, which is not related
to GMP or regulatory
conformance requirements e.g.
Environmental Health and Safety,
but does warrant attention by the
auditee.
CAPAs do not need to be agreed
with the lead auditor.
6
Good
Practice
Demonstration of exemplary
achievement of compliance, or
setting a precedent within the
current industry standard.
7
Categorisation of Audit Findings
Audit Findings Classifications
Dependent on the nature of the findings and the risk associated with any non-
compliance the following categorisations should be used:
Disclosed and
Managed
• The scope of the risk has been defined.
• The root cause(s) have been identified.
• A solution specification is in place.
• Remedial, corrective and preventive actions have been
identified.
• The actions are assessed as effective to address the root
cause i.e. the auditor believes that the plans will reduce the
risk.
• Actions have owners and target dates.
• The status of the plan is monitored routinely.
• Actions will reduce the risk in an acceptable timeframe and
are progressing to schedule.
• There is a process to assess the impact of any changes to
the plan (including date extensions) and approve those
changes.
Disclosed and
Incompletely
Managed
• The scope of the risk has not been defined.
• The root cause(s) have not been identified.
• A solution specification is not in place.
• Remedial, corrective and preventive actions have not been
identified.
• The actions are not assessed as effective to address the root
cause i.e. the auditor believes that the plans will reduce the
risk.
• Actions do not have owners and target dates.
• The status of the plan is not monitored routinely.
• Actions will not reduce the risk in an acceptable timeframe
and are not progressing to schedule.
• There is no process to assess the impact of any changes to
the plan (including date extensions) and approve those
changes.
8
Audit Identified Issues identified during the audit.
9
Findings
Audited System: Management
The self inspection GQP No. (1211) was reviewed. During this audit the self
inspection reports dated on 11/2/2009 &25/1/2009 for SG and wets were
reviewed.
FindingClassification: Audit identified-
Note
Reference:
[ GQP1202]
Risk management :
-During 2008 there were 13 complaints related to oily and leaked capsules and one rework for re-
insertion of Supravit capsule B.N 080858A due to capsule leakage. The risk log of S.G department
has a green risk No.SG 02 dated on 8 July 2007,it has been described as (Leakage of S.G
capsules after quality release) with risk index value 4.
By discussion with the area owner it was noticed that those complaints related to batches were
manufactured during 2006 and many CCRs were raised to solve this problem .
-There is no document for risk revaluation and monitoring of the after action review to ensure that
the previously taken corrective actions are effectively implemented and they are sufficient to
prevent the recurrence of this deviation in the future and reassess the likelihood value of this risk .
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
FindingClassification: Audit identified-
Minor
Reference:
GQP1211
10
Self inspection :
In complete CAPA management system of Level one audit .There are many overdue CAPA s
and delay in the target completion dates
-The CAPA identified in the level 1 audit doesn’t perform in its due date. There was a delay in
IQ&OQ of balance of soft gelatine department. Many work orders were initiated related to epoxy
work, fixation of backstop in soft gelatin but no further progress has been done.
-The self inspection of soft gelatin& wets department mentioned that the calibration of equipment
were reviewed and confirmed while there were many defected devices have no label indicated its
status ( out of use and not calibrated) as recommended inQD574/08.the defected device such as
(the defected temperature indicator of the Diessel tank , the dial thermometer of Diessel holding
tank 3000 l in wets area )& (Stirrer RPM indicator and rotational speed indicator in S.G
department)without label (not calibrated ) .
-In self inspection report of wets area there was an observation related to creation of Arabic
version of SOP without mentioning the SOP number and the target completion date which
required for effective follow up and CAPA closure.
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
Audited System: Personnel
This clause was not covered during this audit.
Audited System: Documentation
GQP3201 Was reviewed
11
Finding Classification: Audit identified- Minor Reference:
[ GQP321
Documents and Data :life –cycle management.
-The log book of IWKA drops packaging machine ( ), had detached papers of APP II of SOP No.
GP 002/01.the log book was not identified by page numerical numbers. Some records missed the
machine name.
-This machine used in packaging of Amproxol drops that exported to EU market. The Machine
data and documentations must comply with the packaging process requirements and provide the
correct information that could be used during problem investigation.
- Incomplete distribution system of electronic SOP was noticed for engineering procedures. The
SOPs hard copies are distributed and controlled by quality department while the electronic
versions were archived in connectware named GMS sops that had an obsolete version of SOP
Number EP 317/07.
Recommendation :
-Effective documentation system must be implemented for drops packaging machine.
-The electronic versions of SOP s must be reviewed and ensure that the current procedures are
available to be used by all authorized users
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
Audited System: Facilities
The following systems were reviewed during this audit.
Facility design (GQP 4201), Air quality (GQP 4204), Compressed gas systems (GQP4206),
Vacuum system (GQP 4210), Facility operation (GQP4301), Calibration (GQP 4304) and
Monitoring and review of environmental controls and utilities environmental (GQP 4401).
-The L4 CAPA for MOH and Ukraine audits were reviewed and closed on time. The air lock
alarms have been installed in soft gelatine and wets area. The status of manufacturing
processes was identified & all rooms had their unique identification numbers.
-The CAPA related to finding number FND-L3-0096034 of L3 GQA audit 2008 was reviewed
and it is ongoing and planned to complete on time to dedicate a storage area for bulk soft
gelatine capsules.
-The CAPA for the previous level two audit were reviewed
12
Finding Classification: Audit identified- Minor Reference:
[ GQP321
Documents and Data :life –cycle management.
-The log book of IWKA drops packaging machine ( ), had detached papers of APP II of SOP No.
GP 002/01.the log book was not identified by page numerical numbers. Some records missed the
machine name.
-This machine used in packaging of Amproxol drops that exported to EU market. The Machine
data and documentations must comply with the packaging process requirements and provide the
correct information that could be used during problem investigation.
- Incomplete distribution system of electronic SOP was noticed for engineering procedures. The
SOPs hard copies are distributed and controlled by quality department while the electronic
versions were archived in connectware named GMS sops that had an obsolete version of SOP
Number EP 317/07.
Recommendation :
-Effective documentation system must be implemented for drops packaging machine.
-The electronic versions of SOP s must be reviewed and ensure that the current procedures are
available to be used by all authorized users
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
Audited System: Facilities
The following systems were reviewed during this audit.
Facility design (GQP 4201), Air quality (GQP 4204), Compressed gas systems (GQP4206),
Vacuum system (GQP 4210), Facility operation (GQP4301), Calibration (GQP 4304) and
Monitoring and review of environmental controls and utilities environmental (GQP 4401).
-The L4 CAPA for MOH and Ukraine audits were reviewed and closed on time. The air lock
alarms have been installed in soft gelatine and wets area. The status of manufacturing
processes was identified & all rooms had their unique identification numbers.
-The CAPA related to finding number FND-L3-0096034 of L3 GQA audit 2008 was reviewed
and it is ongoing and planned to complete on time to dedicate a storage area for bulk soft
gelatine capsules.
-The CAPA for the previous level two audit were reviewed
13
• The risk of finding was described as (lack of assurance that product
quality is not compromised due to the required arrangement for
facilities) ,the CAPA was effectively closed . The batch records of Haemoton
& Supravit capsules have been updated to include the microscope for the
IPC test that has the plant No.1268.
• The risk of finding has been described as (Risk of possibility of product
contamination due to unsuitability of level of control on operations )In
the Soft Gelatin department all the cleaning equipment, holding containers
were labeled and had its identification label.
• The risk of finding has been described as (Risk of lack of assurance that
existing controls establish a base line of local environmental isolate )
the CAPA was closed ,the identification reports of non sterile areas and one
identification report for atypical result of iron oxide raw material were
reviewed and found satisfactory & comply with the GQP 4401 and CAP 044.
-The cleaning records of soft gelatine department were revised refer to SOPs No SG
103/04,SG 112/04,SG 104/08 and SG 105/04 and were found satisfactory , during this audit
the soft gelatin department had a good house keeping and looked clean and tidy .
-During this audit the compressed gases monitoring results for soft gelatine and wets
departments were reviewed refer to SOP EP350/01&QD 583/05and found comply with the
GQP 4206.
-The microbiological environmental monitoring of wets and soft gelatine results were reviewed
.refer to SOP QD 583/05 and found satisfactory.
-The vacuum system for soft gelatine and wets area are dedicated and not shared.The risk
number SG05 in the risk log (Medicine contamination in case of electricity cut off was
disclosed and managed by installing double non return valve and water trap for the medicine
mixing vessel.
The previous L2 audit finding related to the air quality of wets area was closed and the
particulate air count for 0.5 micron were taken and the records dated on 7/5/2008 were
reviewed and found comply with the GQP4204.by reviewing the Sop EP 317/08 the
particulate count for 0.5 micron or greater was performed .
FindingClassification: Audit identified-Major Reference: GQP4301
14
Facility Operation :
I-Wets manufacturing area :
Deterioration in utilities maintenance that increases the possibilities of particulate cross
contamination.
The following observations were detected due to delay in implementation of the planned maintenance
shout down.
-The wall covings of syrup & topical preparation rooms had cracks and need repairing. The
ceiling and partitions of syrup preparation room need repainting
-The stopbacks bars in the topical preparation room were damaged.
-The exit HVAC grill of syrup preparation room wasn’t clean and had a red stain dust.
- Water leakage from the sanitary valve of the topical wash bay purified water loop.
-Damage of temperature control unit in the topical wash bay.
- Water leakage from TE3 steam line jacket.
-The Syrup purified water loop has an attached long welded hose.
Inadequate physical contamination control due to presence of particulate shedding material in the
manufacturing area.
-In topical preparation room there were carton boxes (Secondary pack of Supocire item No. W
01600.00 B.No. 2008251004 )that used in preparation of Abimol suppositories
-Inside the Sarong suppositories filling machine there was a sheet of paper used as lighting lab
cover to reduce the light reflection.
15
Incomplete check of the cleaning record to ensure the effectiveness of the cleaning
procedure.
- The cleaning record of holding tank was not including the cleaning after the previous
manufactured product ( Septrin suspension B.N 091050 ) prepared on 23 March 2009 as
recommended in SOP WP 101/08 cleaning is carried out after each prepration.
-The APP I of SOP (WP 101/08) does not include the batch number of the last manufactured
product to enhance checking of the cleaning procedure and follow up.
Recording of product batch number will help in checking of cleaning record to know if the
manufactured product is the last batch of campaign so the cleaning method mentioned in SOP
(WP101/08) must be applied after completion of campaign.
- In the topical preparation room, the Melter hadn’t label indicate that was under cleaning after
preparation of Dermovate cream B.N. 091100. And the cleaning records of TE3 were not checked
since 2/3/2009.The plastic baskets of manufactured bulk topical tubes were un- cleaned.
II-Soft Gelatin Department :
-The colouring room wall had a crack and need repainting .There are many cracks in the gelatin
stirrer protective D -shaped wall.
-The Floor epoxy of CAM 2 room had a crack and need repairing.
-The hopper plastic cover of CAM 2 (1050) was broken.
-Deterioration of the MK5 gelatin lines thermal isolation.
-Due to the extension project of the soft gelatine department. In the inspection room there was a
wooden partition placed to separate this room from the working area .
Most of the above observations in soft gelatin department were identified in the L1 audit but there
is no further action has been taken.
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
16
FindingClassification: Audit identified-Major Reference:
[GQP4204]
Air quality :
Lack of assurance that air of the correct particulate quality is supplied to areas to
protect product from environmental contamination).
The particle count of 0.5 micron or greater wasn’t performed in soft gelatin manufacturing area as
recommended in GQP4204. the SOP EP 317/08 mentioned monitoring of particle size 5 micron
only.
Recommendation :
-Perform the non viable particulate count of 0.5 micron in soft gelatine manufacturing department
refer to the GQP 4204 to ensure the correct air quality is supplied to the manufacturing areas
where the material and products are handled.
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
17
Finding Classification: Audit identified-Minor Reference:
[ GQP4401]
Environmental controls and utilities.
Incomplete check of temperature &Relative humidity in the encapsulation room .There is no
accurate device for environmental monitoring in the encapsulation room for continuous
checking.
a -The batch record of Supravit capsule bulk page No.22/32 has an instruction to check the
Temperature and Relative humidity (RH) of the drying tunnels: (the limit for RH is 20% ± 5 and
{15-25} for temperature).
-During the encapsulation of Haemoton B.No. 0090917 the Batch record signed checked while the
reading of temperature /RH monitoring device was 18.18 c &96.47% accordingly) .The Temp.RH
reader had an inaccurate reading while it has a valid calibration date till 23/4/2009.
-The operators signed the batch records based on the control and monitoring of Soft gealtin
manufacturing area that is carried out by Building manufacturing system (BMS ) using Stiva
monitoring device placed in the second floor which is not accessibleto the operators .By printing
the actual temp.&RH for the encapsulation room from the (BMS )it was for RH: 17% and Temp :
23.5
b-The SOP EP 317/08 does not include the environmental air condition limit of the drying tunnels.
It has the air condition limit for the encapsulation room NMT 24 C and NMT 50% relative humidity.
The air condition monitoring and control of drying tunnels is essential and had a direct impact on
product quality and affects on the capsules drying process .
Recommendation :
-Continuous accurate monitoring system must be placed at the manufacturing area to be
accessible to the operator .The signature on the batch record must be based on actual
temperature checking.
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
18
Finding Classification: Audit identified-Major Reference:
[ GQP4304]
Calibration :
There is no document highlighting the product quality impact in case of an instruments
calibration failure or instrument defect. The Notification of SOP No. GP 321/08 does not assess
the risk associated with instrument defect.
Absence of documented risk assessment of defected machines represents a risk from lack of assurance that the
equipment used in the manufacturing area are not source of significant risk to product.
By reviewing the Calibration list of Soft gelatin and wets area ,there were many examples of defected
spare parts as follows:
- The dial thermometer of Diessel suspension tank Ref.No. 154/T1 & Product temperature
indicator of Dissel preparation tank Reference Number 1166/T1& 183/T1 were defected and
need to be replaced since August 2006 and no further action has been taken to repair the
defected device or remove from the calibration list .the above devices are classified in SOP
GP 231/06 as’’ Quality critical devices’’.
- Rotational speed indicator Of MK5 Reference No.268/RPM1 & Stirrer RPM indicators of mixing
vessel Ref No. 260/RPM1 were defected since 6/4/2007. those devices are classified as ( EHS
& Business )
- Refer to the SOP GP 231/06 both quality critical and EHS/Business critical need planned and
regular calibration while their related notification reports were not include the target
replacement date or its impact on the product quality.
- There is an SOP No. QD 574/08 (action to be taken in case of exceeding calibration due date
or failed calibration requirement) effective on October 2008 in place but it is not for the device
has been defected before .the in use of this sop will be reviewed in next audit.
- The RH &Temp chart recorder (plant number 001266) had a valid calibration date till 23/4/2009
while its reading had an inaccurate values (RH: 96.47) & (Temp.:18.8 C). So the instrument is
in use while it exceeds its permitted limits.
Recommendation :
-Comply with the GQMP 4002 requirement in respect to perform a quality impact assessment for all
items on the maintenance list to determine its impact on the product quality.
- Perform a detailed risk assessment in case of machine or equipment calibration failure to ensure
the risk is fully understand and appropriate mitigation plan is implemented.
-Any equipment not performing as its permitted limit must be identified as out of use.
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
19
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations will be
addressed sufficiently to achieve compliance].
20
Audited System: Material and Product Control
The following systems were reviewed during this audit. Material and product labelling (GQP
5203), Storage and handling of materials and products (GQP5209) and Rejects and disposals
(GQP 5211)
-The CAPA related to L4 of Ukraine was closed and the batch record of (Vitamin capsule two
colours) has an effective date 25/3/09 (item code AM 310 /01)has been updated to include the
total sample size for work samples in IPC. And the Kg of manufactured bulk capsule to be
translated into number of finished product packs in the batch record of packaging.
Finding Classification: Audit identified -MinorReference:
[ GQP5211]
Reject and disposals:
-In soft gelatine department :
-In batch reviewing room. There were collection bags having blisters of capsules eg. Vitamax plus
capsule 090709 A. Those blisters having label of operator name who perform the leakage test for
rechecking .Those blistered were place in collection bags without labelling until rejection.
During the audit the remedial action has been taken and the blisters placed in plastic basket
labelled by rejected red label.
-The rejected product must be stored in secured controlled place with label to ensure it will not
enter in the manufacturing operation or misused.
Recommendation :
Comply with GQP 5211 for identification and segregation of rejected materials
Response of Auditee
CAPA Details Due Date: [Date for latest completion of all actions required by this CAPA]
[Enter key aspects of CAPA with sufficient detail to establish that all aspects of the observations
will be addressed sufficiently to achieve compliance].
Audited System: Process Assurance
The following systems were reviewed during this audit.
21
Printed packaging components verification and control (GQP 6103), Area line clearance (GQP
4204) and Deviation and investigation handling (6302).
The CAPA related the previous audit l2 finding (possibility of product contamination due to
improper implementation of Area line clearance), The line clearance system was reviewed
during packaging of Haemoton capsules No.090910A and Septrin suspension B.N. 091050 A
and the batch records found satisfactory. the CAPA related to the evaluation of cleaning agent
impacts ,it was included in the cleaning validation master plan document No. COCLEAN /08.
The CAPA related to the yield calculation was reviewed, and there was a visual yield trend for
wets products. This trend should be considered in the periodic product review.
During this audit the mitigation plan for risk has been described as (Product mix up due to
mix up within received printed packaging materials or during packaging operations
that led to single product/single market recall) was reviewed the CAM 2 (1050) barcode
reader was checked and found satisfactory for Haemoton capsule box (50GX AB6001/16 )and Leaflet
(40AB6001/06) .Visiotec Camera for missing capsules was checked and found effectively working.
While the carton box Barcode reader is not working for Vitamax carton box due to the quality of material
or supplier performance issue. Kaizen was conducted to follow the action plan, the progress in the
action plan will be revised in the next audit.
Audited System: Laboratories Controls
This clause was not covered during this audit.
Audited System: Incident Management
This clause was not covered during this audit.
22
Next Steps
• Auditee to submit to lead auditor within 20 working days of
receipt of the audit report details of proposed corrective actions,
including timeframes for the full implementation of each of the
corrective actions. Electronic communication is preferred; hard copy
is not necessary if an electronic copy can be sent.
• Lead auditor to review corrective and preventive action (CAPA)
proposals and send comments to the auditee.
• Auditee (only if agreed with the auditor) to prepare a report of
progress made with actions, at agreed time intervals.
If you have any questions regarding this report or require
clarification on any issues, please feel free to contact me.
We look forward to receiving your CAPA in due course.
Thank you for your co-operation.
Signed and approved……………………….…….Dated:
…………………………
23