Please contact ISPE for more information. Back to Top. Active Pharmaceutical Ingredients. Making sure that the premises and equipment are maintained and records kept; 8. Making sure that validation protocols and reports are reviewed and approved; 9. Evaluating proposed changes in product, process or equipment; and Making sure that new and, when appropriate, modified facilities and equipment are qualified Internal Audits Self Inspection Product Quality Review Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process.
Such reviews should normally be conducted and documented annually and should include at least Personnel Hygiene Lighting Adequate lighting should be provided in all areas to facilitate cleaning, maintenance, and proper operations.
Equipment Maintenance and Cleaning Written procedures should be established for cleaning of equipment and its subsequent release for use in the manufacture of intermediates and APIs These procedures should include: For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed If electronic signatures are used on documents, they should be authenticated and secure Batch Production Records Prepared for each intermediate and API Batch or identification number 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 is allocated Material management Receipt and Quarantine Samples should be representative of the batch 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 Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing.
Contamination Control Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control Examples include residue adhering to the wall of a micronizer, residual layer of damp crystals remaining in a centrifuge bowl after discharge, and incomplete discharge of fluids or crystals from a processing vessel upon transfer of the material to the next step in the process.
Such carryover should not result in the carryover of degradants or microbial contamination that may adversely alter the established API impurity profile. Production operations should be conducted in a manner that will prevent contamination Reprocessing Reworking Batches that have been reworked should be subjected to appropriate evaluation, testing, stability testing if warranted, and documentation to show that the reworked product is of equivalent quality to that produced by the original process.
Concurrent validation is often the appropriate validation approach for rework procedures. This allows a protocol to define the rework procedure, how it will be carried out, and the expected results. If there is only one batch to be reworked, then a report can be written and the batch released once it is found to be acceptable.
Procedures should provide for comparing the impurity profile of each reworked batch against batches manufactured by the established process. Where routine analytical methods are inadequate to characterize the reworked batch, additional methods should be used.
Recovery of Materials and Solvents All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure. Records of complaints should be retained in order to evaluate trends, product-related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.
There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered. The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.
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