Holding & Distribution Procedures 2023 PDF

Holding & Distribution Warehousing Procedures Written procedures describing the warehousing of drug products shall be established and followed. They shall include:  Quarantine of drug products before release by the quality control unit.  Storage of drug products under appropriate conditions o...

Holding & Distribution Warehousing Procedures Written procedures describing the warehousing of drug products shall be established and followed. They shall include:  Quarantine of drug products before release by the quality control unit.  Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected. Temperature Humidity Light Cleanliness According to PIC/S warehousing operations must ensure… Appropriate storage conditions are maintained Allow for appropriate security of stocks. Products are handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Medicinal products should not be stored directly on the floor. Stock should be rotated according to the first expiry, first out (FEFO) principle. Medicinal products that are nearing their expiry date/shelf life should be withdrawn immediately from saleable stock. Stock inventories should be performed regularly and any discrepancies noted investigated. An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The mapping exercise should be repeated for significant changes according to the results of a risk assessment exercise. For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heater / air-conditioner) should be conducted and temperature monitors placed accordingly – PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS Please watch this video and make your own notes regarding the How to carry out temperature mapping study of a warehouse? Make notes on the steps required for temperature mapping study for a warehouse. https://www.youtube.com/watch?v=VC08G2Nk28c Picking Controls should be in place to ensure the correct product is picked. The product should have an appropriate remaining shelf life when it is picked. Distribution Records Records should be kept so that the actual location of the product can be known. For all supplies, a document (e.g. delivery note/packing list) must be enclosed stating:  The date  Name and pharmaceutical dosage form  Batch number  Expiry date  Quantity supplied  Name and address of the supplier  Name and delivery address of the consignee (actual physical premises,  Applicable transport and storage conditions. The primary purpose of this is to ensure that adequate data are available to access trade customers should a recall be initiated. Transport According to PIC/S the required storage conditions for medicinal products should be maintained during transportation within the defined limits as described on the outer packaging and/or relevant packaging information. Storage/Transport Temperature According to PIC/S definition: https://www.gmp-compliance.org/gmp-news/what-are-the-regulatory-definitions-for-ambient-room-temperature-and-cold-chain Transport  Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity.  If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.  If requested, customers should be provided with information to demonstrate that products have complied with the temperature storage conditions.  Cold chain monitoring devices There should be a system in place to control the reuse of cool packs to ensure that incompletely cooled packs are not used in error. There should be adequate physical segregation between frozen and chilled ice packs. VACCINES: What is CTC? Please watch this video and make your notes regarding the Controlled Temperature Chain (CTC) https://www.youtube.com/watch?v=_wnt_3fkxBo In particular consider:  What is the purpose of CTC?  What are the benefits?  What requirements must the product meet to use CTC?