Question: Type A if it conforms the Good manufacturing practices and type B, if otherwise. Newly arrived raw materials were received, transferred to the production area
Type A if it conforms the Good manufacturing practices and type B, if otherwise.
- Newly arrived raw materials were received, transferred to the production area and were used right away as ingredients for a tablet formulation.
- Adding the active pharmaceutical ingredient to syrup formulation using a sifter.
- Obtaining of bottled syrups during filling and measuring their volumes in the filling section/area and not in the QA/QC area.
- Bottled syrups are transferred to another area, distant from the filling area, for capping.
- Developing an SOP in the formulation of all types of syrups.
- Warehouse personnel collect the documents of newly arrived raw materials through window and check the contents in the delivery documents.
- Quarantined materials are separated by placing them in a cage storage.
- Processing work order contains the yield of the production.
- QC department conducts analysis on raw materials and finished products.
- Production manager requests for the latest approved raw materials for a certain batch of production.
- The finished products are kept in the quarantine area while waiting for the approval.
- Packaging of two batches at one time and one area saves a lot of time consumed.
- Quality control is conducted to the product content only.
- A batch of syrups is reprocessed due to volume deficiency of some of the samples obtained.
- Batch number is printed on the immediate label, secondary packaging and boxes.
Reference:
https://www.who.int/medicines/areas/quality_safety/quality_assurance/GuidelinesPackagingPharmaceuticalProductsTRS902Annex9.pdf
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients
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