6. Documentation and records
main points:
All documents related to the manufacture of intermediates or API should be prepared, reviewed, approved and distributed according to written procedures. Such documents can be in paper or electronic form.
The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories.
A procedure should be established for retaining all appropriate documents (e.g.. development, history reports, scale-up reports, technical transfer reports, precess validation reports, training records, procedures records, control records, and distribution records). The retention periods for these documents should be specified.
All production, control, and distribution records should be retained for at last 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.
Equipment Cleaning and Use Records
Records of major equipment use, cleaning, sensitization and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.
Records of Raw Materials, Intermediates, API Labelling and Packaging Materials
Master Production Instructions (Master Production and Control Records)
To ensure uniformity from batch to batch, master production instructions for each intermediate and API should be prepared, dated, and signed by one person and independently checked, dated, and signed by a person in the quality unit
Batch Production Records (Batch Production and Control Records)
Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch production record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.
These records should be numbered with a unique batch or identification number. dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number es allocated.
Laboratory Control Records
Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays.
Batch Production Record Review
Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labelling, to determine compliance of intermediate or API with established specifications before a batch is released or distributed.
Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed.
All deviation, investigation, and OOS (out of specification) reports should be reviewed as part of the batch record review before batch is released.
7.Materials Management
There will be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of material.
Manufactures of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
Materials should be purchased against an agreed specification, from supplier or suppliers approved by quality unit(s).
Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labelling, container damage, broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined or tested as appropriate, and released for use.
If bulk deliveries are made in non-dedicated tankers, there should be assurance of non-contamination from the tanker.
Large storage containers, and their attendant manifolds, filling and discharge lines should be appropriately identified.
Sampling and Testing of Incoming Production Materials
At least one test to verify the identity of each batch of material should be conducted. A supplier's Certificate of Analysis can be used in place of performing other test.
Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications.
Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit whitin the company's control do not need to be tested if the manufacturer's Certificated of Analysis is obtained, showing that this raw materials conform to established specifications. The lack of on-site testing for these materials should be justified and documented.
Samples should be representative of the batch of material from which they are taken. Containers from which samples are withdrawn should be opened carefully and subsequently reclosed.
Storage
Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate suitably spaced to permit cleaning and inspection.
Materials should be stored under conditions and for a period that have no adverse affect on their quality, and should normally be controlled so that the oldest stock is used first.
Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use.
Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing.
Re-evaluation
Materials should be re-evaluated as appropriate to determine their suitability for use. (e.g., after prolonged storage or exposure to heat or humidity).
Manufactures of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
Materials should be purchased against an agreed specification, from supplier or suppliers approved by quality unit(s).
Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labelling, container damage, broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined or tested as appropriate, and released for use.
If bulk deliveries are made in non-dedicated tankers, there should be assurance of non-contamination from the tanker.
Large storage containers, and their attendant manifolds, filling and discharge lines should be appropriately identified.
Sampling and Testing of Incoming Production Materials
At least one test to verify the identity of each batch of material should be conducted. A supplier's Certificate of Analysis can be used in place of performing other test.
Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications.
Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit whitin the company's control do not need to be tested if the manufacturer's Certificated of Analysis is obtained, showing that this raw materials conform to established specifications. The lack of on-site testing for these materials should be justified and documented.
Samples should be representative of the batch of material from which they are taken. Containers from which samples are withdrawn should be opened carefully and subsequently reclosed.
Storage
Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate suitably spaced to permit cleaning and inspection.
Materials should be stored under conditions and for a period that have no adverse affect on their quality, and should normally be controlled so that the oldest stock is used first.
Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use.
Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing.
Re-evaluation
Materials should be re-evaluated as appropriate to determine their suitability for use. (e.g., after prolonged storage or exposure to heat or humidity).