Process validation, Good Manufacturing Practice

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

In pharmaceutical manufacturing, process validation is an exercise that requires the contribution from different departments, including quality assurance and quality control. It is a requirement for good manufacturing practice (GMP) to ensure that the final product produced is of the expected quality. 

Endotoxins are found in some bacterial sources, such as E. coli. For other products they are considered a contaminant that should not be present and can be controlled by adherence to good manufacturing practices (GMPs). Nucleic acids, once considered a significant risk, are now thought of as cellular impurities, and their removal should be validated [2,3]. Proteins that pose a potential risk (e.g., immunogenicity) include host cell proteins, aberrant protein product, proteins used in cell culture, and those associated with the process (e.g., protein A affinity ligands or nucleases employed to reduce viscosity). 

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation. This document is the basis for Annex 15 to the EC Guide on Good Manufacturing Practices for Medical Products. Figure 4 displays the most commonly used topics to be described in a VMP. 

PIC (1989) Guide to Good Manufacturing Practices of Pharmaceutical Products, PIC-Doc PH 5/89 (now PH 1/97 (rev. 2) [7]) Validation of critical processes, significant amendments to manufacturing processes, significant amendments to manufacturing processes, and of all sterilization processes and test methods stipulated. 

World Health Organization. Guidelines on the Validation of Manufacturing Processes. Annex 5 to Good Manufacturing Practices for Pharmaceutical Products (Ref. 14). Geneva (1993). 

Validation Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected results (see also qualification) (EU PIC/S). 

Quality, efficacy, and safety of a medicine are attributes to be planned and established throughout the production process. This concept is especially valid for the production of biologies to assure the fundamental characteristics of efficacy and safety to the patient in each vial of every lot. Every step of pharmaceutical manufacturing should follow high standards intended for production consistency and product quality. The principles defining these standards are described in the Good Manufacturing Practices (GMP) publications. 

WHO (1996), Good manufacturing practices guidelines on the validation of manufacturing processes, Geneva, pp. 81-95 [Technical Report Series no. 863]. 

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