Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes process validation activities in three stages.
• Stage 1 - Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 - Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
• Stage 3 - Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
BATCH RELEASE
Production shall submit Batch Manufacturing Record and Batch Packaging Record after review and approval by Production Officer/ Executive and final review of Head, Production to QA for onward review by Quality Assurance.
On receipt of the batch records (both batch manufacturing and batch packing records), Officer/ Executive Quality assurance shall review the documents for any discrepancy or deficiency, which impacts the product quality/ customer safety or licensing compliance or marketing authorization.
Head, QA, while certifying a batch for release, shall ensure that the batch of the concerned product complies with the requirements of the product registration/ registration dossier/ marketing authorization/license and all other requirements regarding the manufacture, quality control and batch release of pharmaceutical products for sale.
APQR
PQRs are a requirement in PIC/S Guide for GMP, Clause 1.4.
Regular periodic or rolling quality reviews of all registered pharmaceutical products, including export­ only products, should be conducted to highlight any overall trends (not necessarily visible with other quality systems) and to identify product/process improvements by verifying and identifying:
• the consistency of the existing process(es);
• trends in product data;
• the appropriateness of current specifications for starting materials, intermediates and finished products;
• to verify compliance of the registered particulars of pharmaceutical products (Marketing Authorisation);
• deficiencies not detected by routine testing, monitoring or performance metrics; and
• identify opportunities for product and process improvements.
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