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Biomanufacture
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
From the validation master plan, validation protocols are written to experimentally examine each critical step of a manufacturing process. Validation of a facility might involve dozens or even hundreds of protocols. A protocol breaks down a system into simple parts and describes each critical parameter, quality attribute, and operational specification. It ensures that attributes are measurable and testable and that each measurement is scientifically sound. Specifications are developed for results derived from each test or measurement. Validation activities are spelled out in detail, usually with standard operating procedures, production records, and testing instructions, and these are identified in the protocol. The work is done by scientists and engineers, working closely with quality assurance professionals, and it is normal to employ consultants and contractors to assist employees with these herculean efforts. Good statistical practices are also utilized in most protocols. Validation is fully documented, from the master plan to the final validation reports. Validation has a pass-versus-fail outcome; either one meets all the predefined specifications outlined in the validation or the validation fails. Validations are labor intensive, time consuming, which make them costly. With this in mind, the prudent biomanufacturer ensures that all systems are performing as expected before executing validation protocols.
Validation in Europe—What Are the Differences?
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Annex 15 describes some validation requirements that are slightly different from the expectations of the FDA. These include: A description of the contents of the Validation Master Plan (VMP) as a “validation programme” for all facilities, systems, equipment and processes to be validated, which implies that the VMP covers the entire facility. It recognizes, however, that large projects may require separate VMPs, which is more akin to the US FDA concept of the VMP.A statement regarding the acceptability of a “worst-case” approach for cleaning validation.Guidance regarding the qualification of established (in-use) facilities, systems and equipment. Annex 15 was significantly revised in October 2015, and there were some subtle but significant changes in this revision. Perhaps most significantly, it makes clear statements about prospective, concurrent and retrospective validation. Concurrent validation should only be performed “in exceptional circumstances”. It also makes an ambiguous and noncommittal statement related to retrospective validation that “processes in use for some time should also be validated (retrospective validation)”. This statement is open to interpretation, but the common interpretation by EU regulators is that if a process has been in use for some time, then it should have been validated “some time ago”. Retrospective validation is not acceptable for new processes. The expectations for process validation have been known for some time and as far as the EMA is concerned all registered processes should have been validated by now.
Quality and lifecycle management
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
The validation master plan (VMP) is a document that contains many components of QA systems; it begins with the process development and is updated throughout the process. An appropriate validation plan reduces the risk of missing out essential components in the CMC section, assures batch compliance. The process validation is a major component of the VMP and includes such elements as Acceptance criteria for every analysis o in process materials, API and DPIdentification of all analytical methods used including plans for qualification and validationCharacterization of the cells used for propagation into cell cultures. The program comprises cell line history, substrate and raw material characterization, test for microbial agents, fungi, mycoplasma, viruses, and prions. The ICH guideline on cell characterization is usually followedIdentification of critical parameters for each unit operation. Statistical factorial design is used to identify critical parametersStability studies, both short term and long term For the productFor intermediary products stored for a certain amount of time. Product stability under the given storage conditions must be assured throughout the storage periodProcess robustness testing results include specified parameter intervals, identification of critical parameters by statistical analysis, recoveries, yields, batch data, column and filter performances, columns and filter life timesFlow sheets describing every unit operation
Two-level process validation approach for medical devices
Published in Journal of Medical Engineering & Technology, 2019
FDA Guidance for Industry, Process Validation: General Principles and Practices (January 2011)EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annexe 15: Qualification and Validation (March 2015) [4]PIC/S – Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation (September 2007) [5]In order to facilitate the understanding of the process validation approaches in the validation guidance documents, all of their key points related to process validation approach are extracted and analysed in Tables 1–4.