SOP on Time Limitations on Production
1.0 Purpose: This SOP describes a time limitation for various steps involved in manufacturing process of a product batch.
2.0 Scope: This SOP applies to Production staff.
3.0 Responsibility: Production Manager to ensure that procedure is followed.
4.0 Materials and Equipment: As required
5.01 When appropriate, time limits for completion of each phase of production is established to assure the quality of drug product.
5.02 Deviation from established time limits may be acceptable if such deviation does not compromise quality of drug product.
5.03 Any such deviation is justified and recorded.
5.04 Materials are susceptible to microbial attack. Bulk materials are filled or formulated and packed within 48 hours; otherwise any microbial contamination can result in high levels of microbial load.
5.05 Materials subject to oxidation may be protected with nitrogen. Effective nitrogen protection may be difficult at bulk stage. The process must be completed within 48 hours.
5.06 Tablet granulations or other bulk solids may adsorb or release moisture on storage, making them more difficult to process or even accelerating decomposition. Batch should be completed within 48 hours. If an accepted holding time-scale of 48 hours has been extended to 60 hours or more with no adverse impact, it may be possible to change accepted holding time to 60 hours or more.
5.07 In the event that a defined time-scale is exceeded, this may not necessarily result in batch rejection. But an investigation must be initiated to identify the cause and the possible implications of the changed time-scales.
6.0 Reporting : Any deviation in the time-scale should be reported to Quality Assurance Manager to evaluate the possible adverse impact on the drug product batch.