GMP Documentation

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GDP

cGMP DOCUMENTATION REQUIREMENTS

(Good Documentation Practices)2

Document….?

The document is information (meaningful data) and its supporting medium, which could be..

In paper form,CD, Computer Files, Or Microfilm.

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DOCUMENTATION

Documentation..?is the key to GMP compliance and ensures

traceability of all… development,

manufacturing and testing activities.

provides the route for auditors to assess the overall quality of operations within a company and the final product.

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DOCUMENTATION

Documentation..?

provides the route for auditors to assess the overall quality of operations within a company and the final product.

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DOCUMENTATION

Good Documentation..?An essential part of the quality assurance

system. Clearly written procedures prevent errors

resulting from spoken communication

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DOCUMENTATION

Inclusions Of Documentation !!!The following documents (not limited to it):RecordsLabelsSpecifications And Testing ProceduresMaster FormulaePackaging InstructionsBatch Manufacturing Records (BMR)Batch Packaging Records (BPR)Standard Operating Procedures (SOPs)

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DOCUMENTATION

Maintenance of Documents: Documents, as required under local rules*, shall be meticulously (Thoroughly) maintainedregularly reviewedkept up-to-date, (i.e. Document Control System).

* Drugs Rules -1976- Schedule B-II Part I

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DOCUMENTATION

Records of Action: traceable.

Batch Records : shall be retained for at least…five year after the expiry date.

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DOCUMENTATION

Documentation Systems: Data may be recorded by …

Electronic data processing systems or By photographic or Other reliable means. be Available and The accuracy of the records shall be checked.

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DOCUMENTATION

Only authorized persons shall be able to enter or modify data in the computer, Maintain a record of changes and deletion;

Access shall be restricted by;Passwords or other meansThe entry of critical data shall be

independently checked.Data shall also be readily available.

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DOCUMENTATION

Status Identification:…..Labels applied to…

containers, equipment, or premises shall be…… Unambiguous (clear) andIn the Company’s Agreed Format.

Ambiguous Documents

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DOCUMENTATION

Status Identification:The labels of different colors to indicate the status such as;

“Quarantined - Yellow”, “Accepted - Green”,“Rejected - Red”,

may also be used in addition to the wording.

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DOCUMENTATION

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• Name of product• Ingredients• Net Content

• Batch number• Expiry date• Storage condition

• Information about manufacturing company (Lice. No. and Address)

Finished Product Labeling:

Shall be labeled in accordance with the Drug (Labeling and Packing) Rules 1986.

DOCUMENTATION

Reference Standard Identification: (for QC Lab)

For reference standards, the label or accompanying documents shall indicate;

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DOCUMENTATION

• Name of material• Purity/ Potency• Date of manufacture

• Batch number• Shelf-life/ Expiry Date• Storage condition

Specification approvals:

Specifications should be available for :

Each specifications shall be;Approved and, Maintained by the quality Assurance.

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DOCUMENTATION

• Raw Materials• Finished Products (Bulk & Intermediate Product)• Packaging Materials

Bulk & Intermediate Product

Revision of Specification: Periodic revisions to comply with….

new edition of the National Pharmacopoeia or

other Official Compendia or the Drugs (Specifications) Rules 1978.

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DOCUMENTATIONUSP

BP

DR

Batch Processing Records: During processing, the following information shall be;

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DOCUMENTATION

• A batch Processing Record shall be kept for each batch,

• Transcription Errors

Checking Work Station: Before any processing begins,

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DOCUMENTATION

• A check for previous Products,• Documents or Materials not required for the planned process,•Equipment is clean and suitable for use,•Check shall be recorded

Recording Process Operation: During processing, the following information shall be;

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DOCUMENTATION

• Time of action taken• Signed by responsible for Operation Completed• Name of Product• Batch No.•Date and time of commencement of significant stages of production

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DOCUMENTATION

•The name of the person responsible for each stage• The initials of the operator(s) of different significant steps of production • Person(s) who checked each of these operations (e.g. weighing);

Recording Process Operation: Continued…

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DOCUMENTATION

• The batch number and /or analytical control number

• The quantity of each starting material actually weighed including the…• Batch/Lot number and • Amount of any recovered or reprocessed material added;


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DOCUMENTATION

• any relevant processing operation or event, • the major equipment used; • the in-process controls performed,• the initials of the person(s) involved,• and the result obtained;


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DOCUMENTATION

• Yield together with comments or explanations for significant deviations from the expected yield; and

• notes on special problems including details, with signed authorization for any deviation from the master formula.


Pre-packaging Line Check:

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DOCUMENTATION

• A batch packaging record shall be kept• to avoid transcription errors.

Batch Packaging Records:

• A batch packaging record shall be kept

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DOCUMENTATION

• by Name and signature.• the name of the product, • the batch number, • the quantity of bulk product• the batch number and the planned quantity

of finished product obtained, • the quantity actually obtained,• the reconciliation;

Recording of Packaging Operation:

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DOCUMENTATION

• the date(s) and time(s) of the packaging operations,

• the name of the responsible person,• batch number,• the checks for identity & conformity,

including the results of in-process controls;

Recording of Packaging Operation: : Continued…

Details of the packaging operations carried out, including…

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DOCUMENTATION

• references to equipment, • the packaging lines used,• samples of the printed packaging materials

used,• expiry date, &• any additional overprinting;

Recording of Packaging Operation: : Continued…

The quantities and reference number ,

Identification of all printed packaging materials

Bulk product issued,

Used, destroyed, or returned to stock and …

The quantities of product obtained to permit an adequate reconciliation.

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DOCUMENTATION

the initials of the persons who performed the testing;

the initials of the persons who verified… the testing and the calculations, where appropriate; and

A clear statement of Release or Rejection (or other status decision) dated signature of the designated person.

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DOCUMENTATION

RELEASED

Recording Batch Numbers: Batch-number shall be recorded

in a Logbook,

with product… Logbook identity, and size of batch.

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DOCUMENTATION

Recording Batch Numbers:

In addition to the batch number, references of the relevant specifications

and testing procedures;

test results, including… observationscalculations, dates of testing;

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DOCUMENTATION

Equipment Logbooks:Logbooks shall be kept with equipment and

record, as appropriate, any… validations, calibrations, maintenance, Logbookcleaning, or repair operations including dates and the identity of

the person who carried out these operations.

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DOCUMENTATION

Equipment Utilization Record:Use of major and critical equipment, areas,

Where products have been processed….

shall be …

recorded in Chronological order (In Sequence).

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DOCUMENTATION

Reasons for GMP Documentation Requirements

1) Practice Good Business Sense

2) Fulfill Regulatory Requirements

3) Prevent Mix-ups and Errors

DOCUMENTATION

Documentation Key CharacteristicsTo ensure GMP Compliance, all

documents must be: accurate complete & verified clear reliable legible retrievable permanent current

Principles for Good Documentation

Reviewers of documents/records must be sufficiently trained. All errors detected during record review must be

immediately Corrected Documented

DOCUMENTATION

Documents preparation, review, and approval processes must be

defined by operating procedure(s).Documents must be ….

periodically audited.

Principles for Good Documentation

DOCUMENTATION

DOCUMENTATION

Basics: Always keep the document concurrent

with process recording information and signing immediately after the step is performed.

signatures / initials should… be legible, recorded in the correct blanks, Use a permanent ink. For example;

Black or Dark Blue Permanent Ink is strongly encouraged.

DOCUMENTATION

Do not use downward arrow (), “ditto marks”,

or “squiggle s”, to record repeated data in a column

_______ _________ _________

________ __________ ___________ ________ __________

___________

_________ __________ ___________

________ __________ ___________

JWC 20-Dec-2012 JWC 20-Dec-2012 JWC 20-Dec-2012

DOCUMENTATION

Write and record information neatly to make the document legibleKeep document clean by not placing random marks on itDocument cross-outs and write-overs of digits or characters correctly, by writing your initials & date of the correction near the cross out

Incorrect: 187 187 • Do not try to remove all traces of Correction 187Never use correction ink, correction tape or erasable pens

189JWC 20-Dec-2012

DOCUMENTATION

Example 1 4 7 5 Example 2 4 5

Number should be crossed-out with one line, initialed and dated. Unclear what the number is.

All corrections should be made the same way.475485

JWC20-Dec-2012

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DOCUMENTATION

Measurements:Ensure that all records include units of measurement for ….

• volume, • weight, • pressure etc.

Examples:

3.56 kg / 300 mL

DOCUMENTATION

1) Follow the organization’s accepted format for recording dates ..i.e. dd-mm-yy (04-12-2013) is standard format Don’t Use mm-dd-yy (12-04-2013) etc.

2) Be consistent…• across your organization• in your own work

DOCUMENTATION

Time:be complete and indicate which part of the day the operation took place i.e. 10:08 am or 10:08 pm

follow the organization’s accepted practice for recording time format

i.e. 10:08 am or pm

DOCUMENTATION

Recording Data and Calculations:

Ensure that…

• the decimal points are in the correct position.

• the digits in numbers have not been reversed.

• the number of significant digits is correct.

DOCUMENTATION

Protect the document from • spills• excess folding• other physical damage• random marks

A Little Documentation Respect

DOCUMENTATION

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THANKS