Generic Rework/Reprocessing Procedure

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Noel Townsend

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I'm trying to write my rework and reprocessing procedure and want to see a couple good examples or some advice. I am hoping to create it all in one document. Contract filling of OTC pharmaceuticals. Level 8 cleanrooms.
 
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v9991

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Noel Townsend said:
I'm trying to write my rework and reprocessing procedure and want to see a couple good examples or some advice. I am hoping to create it all in one document. Contract filling of OTC pharmaceuticals. Level 8 cleanrooms.
Click to expand...

with the limited information and certain assumptions, SOP to cover
1. systems :- processing controls - qc - material controls - storage - batch release - criteria on handling the reprocessed materials and affeted batches.
2. process :- affect on validation status and stability impact of the product/batch
3. regulatory and customer implications.

following references could lead to certain insights of what to cover.,
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report: Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles: Quality management in the drug industry: philosophy and essential elements 1 : 14. Materials: Rejected, recovered, reprocessed and reworked materials

https://www.ema.europa.eu/documents...tive-pharmaceutical-ingredients-step-5_en.pdf

https://www.ich.org/fileadmin/Publi.../Quality/Q1F/Stability_Guideline_WHO_2018.pdf

Rejected, recovered, reprocessed and reworked materials
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14.28 Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should either be returned to the suppliers or, where appropriate, reprocessed or destroyed in a timely manner. Whatever action is taken should be approved by authorized personnel and recorded.

14.29 The reworking or recovery of rejected products should be exceptional. It is permitted only if the quality of the final product is not affected, if the specifications are met, and if it is done in accordance with a defined and authorized procedure after evaluation of the risks involved. A record should be kept of the reworking or recovery. A reworked batch should be given a new batch number.

14.30 The introduction of all or part of earlier batches, conforming to the required quality, into a batch of the same product at a defined stage of manufacture should be authorized beforehand. This recovery should be carried out in accordance with a defined procedure after evaluation of the risks involved, including any possible effect on shelf-life. The recovery should be recorded.

14.31 The need for additional testing of any finished product that has been reprocessed, reworked or into which a recovered product has been incorporated, should be considered by the quality control department.
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and especially the relevant sections of ICH Q7.
 

Attachments

  • ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf
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  • SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS s5517e.pdf
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  • Stability_Guideline_WHO_2018.pdf
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C

cosmeticqg

Starting to get Involved
Since the stability guidelines were shared here, does anyone has a good stability protocol for cosmetics to share?
 
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v9991

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here's example document....just in case if you haven't already found themn....
STABILITY STUDY PROTOCOL TEMPLATE - Pharmaceutical Industry - PharmaState Academy
Manual 047 Preparation & Maintenance of Stability Protocols and Stability Master Plans (gmpsop.com)

the cosmetics cover broad range of categories grouped by product/dosage form and application areas; and each one need to meet the specific / particular criteria and challenges.,
in general, the regulations are generally covered under ICH Q1; here's other interesting references for reference to design the stability protocol.
Shelf Life and Expiration Dating of Cosmetics
ISO 18811 Cosmetics — Guidelines on the stability testing of cosmetic product
mdpi Designing a Suitable Stability Protocol in the Face of a Changing Retail Landscape
gUIDELINES ON STABILITY TESTING OF COSMETIC PRODUCTS ALL RIGHTS RESERVED TO CTFA AND COSMETICS EUROPE
 

Attachments

  • cosmetics-08-00064 (1).pdf
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