ESSENTIAL DOCUMENTATION

Essential Documentation
Objectives
To review specific requirements for essential document. To list other types of GMP documents. GMP rules on documents. Documents are historical records of how we practice GMP in pharmaceutical factory.
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Essential Documentation
PURPOSE OF DOCUMENTATION: Essential statutory requirement To be clear of what is to be done To keep records of what has been done To provide audit trials for complaint investigation. To help us decide and take corrective action in case of quality problem.
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Essential Documentation
DOCUMENTATION LEVELS :
The hierarchy of documents is defined in Category 1 Category 2 Category 3
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Essential Documentation
Category 1: The document which are the apex documents of the pyramid, based on which the other documents shall be prepared. The category 1 documents include: Site Master File [SMF]. Quality Manual [QM]. Training Programes [TP] . Validation Master Plan [VMP].
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Essential Documentation
Category 2: The documents which are prepared for the actual execution of the activity. Standard Operating Procedures [SOPs]. Protocols. Qualification Documents. Master Formula Records. Batch Manufacturing & Packing Records. Specifications and method of analysis

Essential Documentation
Category 3: The documents which are the recording formats. The category 3 documents includes Formats & Reports. Logbooks., Technology transfer records
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Essential Documentation
BASIC DOCUMENTS Production Related: Batch Manufacturing records (BMR) Batch packaging records (BPR) These are derived from: Master formulae records (MFR) To operate equipment and processes we needStandard operating procedure (SOP).
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Essential Documentation
BASIC DOCUMENTS Quality Control Related: Material specifications. Product specifications. Analytical method & procedures. Calibration procedures for instrument. Operating procedures for instrument. Microbiological procedures.
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Essential Documentation
OTHER DOCUMENTS: Housekeeping & sanitation logs. Equipment & instrument logs. Validation documents. Annual product reviews. Maintenance & machine history card. Complaint records. Training records.
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Essential Documentation
PRODUCTION DOCUMENTS: MFR: is essentially a specific guide detailing manufacturing and packaging process for a product. It includes instructions on inprocess controls and sampling during the production process. Usually prepared by R & D or Parent Company. BMR/BPR: is an extract from the MFR which gives stepwise instruction on how to process a product. It includes tables and blank spaces to be filled in with observations as the product is processed in the factory. 10

Essential Documentation
BMR INCLUDES AT LEAST THE FOLLOWING DATA: Product name/batch number/batch size/lot size theoretical & expected yields. Actual quantities of each raw material issued and checked. Step wise processing data with time/signature of responsible person for each operations. Key equipment used in the process. Area clearance/equipment cleanliness checks. Environmental checks (temperature/humidity) Inprocess checks. 11

Essential Documentation
BPR INCLUDES AT LEAST THE FOLLOWING DATA: Product name/batch number/pack size/quantity packed. Label type and overprinting details approval (specimen). Reconciliation of materials used in packaging. Issue/ return of material to store. Details of packing operation with time/ signature of responsible person for each operation. Inprocess controls (volume/ weight/ quantity per container) Line clearance. 12 Outer pack and shipper packing details.

Essential Documentation
Standard Operating Procedures WHAT IS AN SOP? These are written and authorized guidelines which describe / tell how to perform certain activities. It defines scope and responsibility of both operator and officer, carrying out these activities. It also warns of consequences of failure to follow the guidelines

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Essential Documentation
Standard Operating Procedures: Who should prepare? Expert/experienced person knowing the operation. Who should check? Department head or manager Who should approve? Q A or designated person Where should the SOP be stored? Original with QA Controlled copy with department Display copy displayed at the work place.

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Essential Documentation
Standard Operating Procedures
Activities which require SOPs? Receipt of all material deliveries Internal labelling, quarantine and storage of materials Operation, maintenance and cleaning of all instruments and equipment Sampling of materials Batch numbering systems Material testing at all stages of production
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Essential Documentation
Standard Operating Procedures Activities which require SOPs? Batch release or rejection. Storage and distribution procedures. Equipment assembly and validation Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation procedure. Personnel recruitment, training, clothing and hygiene Environmental monitoring
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Essential Documentation
PROTOCOLS:

These are also procedures to perform validation activities.

A protocol may include formats/ tables for filling information during the validation activity. Alternatively the protocol may indicate preparation of reports in other standard formats available for the validation activity.
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Essential Documentation
QUALITY CONTROL DOCUMENTS: Material & product specifications List of test to be done with acceptance limits for compliance Analytical methods & procedure : Detailed instruction on analytical test procedures Same test procedures may have pharmacoepial references. Calibration procedures for instrument Detailed test to be performed to ensure correct calibration status.
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Essential Documentation
QUALITY CONTROL DOCUMENTS: Microbiological procedures Sterility testing method Bio assay procedures Total viable count and microbial limit test procedure.

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Essential Documentation
OTHER RELATED DOCUMENTS: Log books: Required for each equipment/ instrument to enumerate what product was processed or tested. Idle time and cleaning time details. Specific break down and repair entries. X- check entries in BMR/BPR etc.

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Essential Documentation
VALIDATION DOCUMENTS: Equipment qualification URS/DQ/IQ/OQ/PQ Process validation Cleaning validation Aseptic media fill validation Analytical method validation.

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Essential Documentation
ANNUAL PRODUCT REVIEW: Key record to check on-going product performance batch wise details of product yields and key quality parameters. MAINTENANCE & MACHINE HISTORY CARDS: List of periodic preventive maintenance, major repairs carried out on each machine. Setup and modification on machine operation.

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Essential Documentation
COMPLIANT RECORDS: Details of market complaints received. Investigation and findings and process improvements. TRAINING RECORDS: Individual training of pharmacist/ chemist/ stores and maintenance persons GMP water / air systems / shopfloor activities workmen training on hygiene & gowning.
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Essential Documentation
STOCK CONTROL DOCUMENTS: Responsibility of stores: Receipt, Issues in stock registers/ computers The records include batch numbers, status, quantities and expiry date Required for: Production planning Purchasing activity Ensuring orderly usage of material FIFO to EEFO.
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Essential Documentation
DISTRIBUTION RECORDS
For distribution, there should be one record per batch of product. It should contain the batch number, quantity and destination of each delivery. Why are these records important? In the case of a product recall, the information on distribution can be obtained rapidly from a single source.
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Essential Documentation
REVIEW OF DOCUMENTATION: Specifications and SOPs. Done by concerned department at periodic intervals 12/24 months OR After any significant change is made. Product BMR/BPR are reviewed by QA prior to each batch release.
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Documentation & Control

Storage / Destruction

Retrieval

Good documentation systems

Approval Review

Distribution Training Authorization

Prepare
Design

Essential Documentation
Other documentation: Labels are also part of documentation Internal labels status/ identity External label product labels LABELS: IDENTITY: Placed on containers, vessels, equipment to IDENTIFY the MATERIAL that is inside. STATUS: Placed on containers, vessels and equipment to indicate CURRENT STATUS of MATERIAL that is inside 28

Documentation & Control

Labels
What must be labelled? What must be on the label? Who has responsibility for labelling? The identification affixed to the recipients, equipment, and facilities and on products should be clear, without ambiguities. Different colors indicating its conditions might be used (e.g.: in quarantine, approved, rejected, clean).

Finished Product Label

Name Active ingredients and amounts Batch number Expiry date Storage conditions Precautions if necessary Directions for use Earnings Name and address of manufacturer
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The approved master of a label need not to be a label itself but may consist of a approved set of relevant data used by or sent to a label printer. A 0-copy of the label may be filled together with the batch record as proof of compliance of the master.

Essential Documentation

Considering the recent trends in the international auditing agencies it has been made very clear that DOCUMENTATION is the heart of the organization and it is the only one evidence(historically) of systematic approach towards quality standards indicated by the systems and practices observed / adopted by the organization.

Rules About Making Records

Always make record, or enter signature etc when (or immediately after) the action or reading has been taken, or the check has been made. Records should always be made as things happen. NOT at the end of the shift, day or week they are about current events, not history.
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Rules About Making Records

A person entering a second check signature or initials is confirming that he or she actually saw what was done (for example, a weighing) and has personally checked that everything was correct (product, material, batch, quantity, reading or whatever). It is NOT good enough, and it could be very dangerous, to just trust your mate to have got it right, and write in second check initials/signatures at the end of the day. These, too should be entered as things happen, when they have been seen to happen. 33

Rules About Making Records

Records should always be NEAT and CLEAR. They do not have to be beautiful, but remember, other may need to read them in five or more years time. If you make a mistake when making an entry on a document. It is not a crime. But if you do make a mistake, do not obliterate it or cover it up, cross it out neatly (so that it can still be read), make the correction and sign/initial and add the date (with any explanation necessary)
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