Process validation and aspects of concurrent release of Process Performance Qualification PPQ batches.
Validation in pharmaceutical manufacturing and any of the process carried out in its process is very important factor as mentioned in current good manufacturing practices guidelines and in the guidelines on process validation published by US FDA in Jan 2011, drug manufactured in the facility not complying validations and current good manufacturing practice (C GMP guidelines) for finished pharmaceuticals are provided in 21 CFR parts 210 and 211 are deemed as adulterated even though it meets all of its standards.
Also see Pharmaceutical Validations here at validations
In most cases, the Process Performance Qualification PPQ study needs to be completed successfully and a high degree of assurance in the process achieved before commercial distribution of a product. In special situations, the PPQ protocol can be designed to release a Process Performance Qualification PPQ batch for distribution before complete execution of the protocol steps and activities, i.e., concurrent release. FDA has stated in the guidelines on process validation published by US FDA in Jan 2011 that they expects that concurrent release will be used rarely.
Concurrent release might be appropriate for processes used infrequently for various reasons, such as to manufacture drugs for which there is limited demand (e.g., orphan drugs, minor use and minor species veterinary drugs) or which have short half lives (e.g., radiopharmaceuticals, including positron emission tomography drugs). Concurrent release might also be appropriate for drugs that are medically necessary and are being manufactured in coordination with the Agency to alleviate a short supply.
Conclusions about a commercial manufacturing process can only be made after the PPQ protocol is fully executed and the data are fully evaluated. If Stage 2 qualification is not successful (i.e., does not demonstrate that the process as designed is capable of reproducible performance at commercial scale), then additional design studies and qualification may be necessary. The new product and process understanding obtained from the unsuccessful qualification study(ies) can have negative implications if any lot was already distributed. Full execution of Stages 1 and 2 of process validation is intended to preclude or minimize that outcome.
Circumstances and rationale for concurrent release should be fully described in the PPQ protocol. Even when process performance assessment based on the PPQ protocol is still outstanding, any lot released concurrently must comply with all CGMP guidelines, regulatory approval requirements, and PPQ protocol lot release criteria. Lot release under a PPQ protocol is based upon meeting confidence levels appropriate for each quality attribute of the drug.
When warranted and used, concurrent release should be accompanied by a system for careful oversight of the distributed batch to facilitate rapid customer feedback. For example, customer complaints and defect reports should be rapidly assessed to determine root cause and whether the process should be improved or changed. Concurrently released lots must also be assessed in light of any negative PPQ study finding or conclusions and appropriate corrective action must be taken (§§ 211.100(a), 211.180(e), and 211.192). We recommend that each batch in a concurrent release program be evaluated for inclusion in the stability program. It is important that stability test data be promptly evaluated to ensure rapid detection and correction of any problems.
GMP guidelines
Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures
What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of pharmaceutical product to foreign countries
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Process Validation guidelines Series
Process validation aspects of Analytical Methodology.
Process Validation Stage 3 The Continued Process Verification.
Process Validation : Process Qualification and Process Performance Qualification (PPQ)
Process Design and Process Validation Recommendations
Process validation and its regulatory, statutory requirements.
Process Validation and Drug Quality Approach to Process Validation.
General Considerations for Process Validation and Recommendations
Validation in pharmaceutical manufacturing and any of the process carried out in its process is very important factor as mentioned in current good manufacturing practices guidelines and in the guidelines on process validation published by US FDA in Jan 2011, drug manufactured in the facility not complying validations and current good manufacturing practice (C GMP guidelines) for finished pharmaceuticals are provided in 21 CFR parts 210 and 211 are deemed as adulterated even though it meets all of its standards.
Also see Pharmaceutical Validations here at validations
In most cases, the Process Performance Qualification PPQ study needs to be completed successfully and a high degree of assurance in the process achieved before commercial distribution of a product. In special situations, the PPQ protocol can be designed to release a Process Performance Qualification PPQ batch for distribution before complete execution of the protocol steps and activities, i.e., concurrent release. FDA has stated in the guidelines on process validation published by US FDA in Jan 2011 that they expects that concurrent release will be used rarely.
Concurrent release might be appropriate for processes used infrequently for various reasons, such as to manufacture drugs for which there is limited demand (e.g., orphan drugs, minor use and minor species veterinary drugs) or which have short half lives (e.g., radiopharmaceuticals, including positron emission tomography drugs). Concurrent release might also be appropriate for drugs that are medically necessary and are being manufactured in coordination with the Agency to alleviate a short supply.
Conclusions about a commercial manufacturing process can only be made after the PPQ protocol is fully executed and the data are fully evaluated. If Stage 2 qualification is not successful (i.e., does not demonstrate that the process as designed is capable of reproducible performance at commercial scale), then additional design studies and qualification may be necessary. The new product and process understanding obtained from the unsuccessful qualification study(ies) can have negative implications if any lot was already distributed. Full execution of Stages 1 and 2 of process validation is intended to preclude or minimize that outcome.
Circumstances and rationale for concurrent release should be fully described in the PPQ protocol. Even when process performance assessment based on the PPQ protocol is still outstanding, any lot released concurrently must comply with all CGMP guidelines, regulatory approval requirements, and PPQ protocol lot release criteria. Lot release under a PPQ protocol is based upon meeting confidence levels appropriate for each quality attribute of the drug.
When warranted and used, concurrent release should be accompanied by a system for careful oversight of the distributed batch to facilitate rapid customer feedback. For example, customer complaints and defect reports should be rapidly assessed to determine root cause and whether the process should be improved or changed. Concurrently released lots must also be assessed in light of any negative PPQ study finding or conclusions and appropriate corrective action must be taken (§§ 211.100(a), 211.180(e), and 211.192). We recommend that each batch in a concurrent release program be evaluated for inclusion in the stability program. It is important that stability test data be promptly evaluated to ensure rapid detection and correction of any problems.
Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures
What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of pharmaceutical product to foreign countries
Process Validation guidelines Series
Process validation aspects of Analytical Methodology.
Process Validation Stage 3 The Continued Process Verification.
Process Validation : Process Qualification and Process Performance Qualification (PPQ)
Process Design and Process Validation Recommendations
Process validation and its regulatory, statutory requirements.
Process Validation and Drug Quality Approach to Process Validation.
General Considerations for Process Validation and Recommendations
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