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.

  1. Newly arrived raw materials were received, transferred to the production area and were used right away as ingredients for a tablet formulation.
  2. Adding the active pharmaceutical ingredient to syrup formulation using a sifter.
  3. Obtaining of bottled syrups during filling and measuring their volumes in the filling section/area and not in the QA/QC area.
  4. Bottled syrups are transferred to another area, distant from the filling area, for capping.
  5. Developing an SOP in the formulation of all types of syrups.
  6. Warehouse personnel collect the documents of newly arrived raw materials through window and check the contents in the delivery documents.
  7. Quarantined materials are separated by placing them in a cage storage.
  8. Processing work order contains the yield of the production.
  9. QC department conducts analysis on raw materials and finished products.
  10. Production manager requests for the latest approved raw materials for a certain batch of production.
  11. The finished products are kept in the quarantine area while waiting for the approval.
  12. Packaging of two batches at one time and one area saves a lot of time consumed.
  13. Quality control is conducted to the product content only.
  14. A batch of syrups is reprocessed due to volume deficiency of some of the samples obtained.
  15. 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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