Pharmaceutical manufacture validation

D.C. Ferreira, Faculty of Pharmacy, University of Porto, Porto, Portugal, Pharmaceutical Manufacturing Validation Principles... 

Process validation is the procedure that allows one to establish the critical operating parameters of a manufacturing process. Hence, the constraints imposed by the FDA as part of process control and validation of an SMB process. The total industrial SMB system, as described, is a continuous closed-loop chromatographic process, from the chromatographic to recycling unit and, with the use of numerical simulation software allows the pharmaceutical manufacturer rapidly to design and develop worst-case studies. 

Manufacturing validation data, which should aim to identify the critical process steps, especially for nonstandard manufacturing processes such as for new dosage forms, should be discussed in the development pharmaceutics section of the application. Validation data may be accepted based on closely related products. In-process control tests and acceptance limits should be included for any aspect where conformity with the finished product tests cannot otherwise be guaranteed (e.g., mixing, granulation, emulsification and nonpharmacopeial sterilization processes). 

Validation studies encompass all aspects of (bio)pharmaceutical manufacture. All new items of equipment must be validated before being routinely used. Initial validation studies should be... 

In addition to equipment, many processes/procedures undertaken during pharmaceutical manufacture are also subject to periodic validation studies. Validation of biopharmaceutical aseptic hlling procedures is amongst the most critical. The aim is to prove that the aseptic procedures devised are capable of delivering a sterile bnished product, as intended. 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

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. 

Validation can be defined as the act of proving that any procedure, process, equipment, material, activity or system leads to the expected results . Routine and adequate validation studies form a core principle of GMP as applied to (bio)pharmaceutical manufacture, as such studies help assure the overall safety of the finished product (Box 3.1). 

In addition to equipment, many processes/procedures undertaken during pharmaceutical manufacture are also subject to periodic validation studies. Validation of biopharmaceutical... 

The purpose is to develop a guideline to validate the efhcacy of the sterility test method for a specihc product or material. The similarity of the validation approach with the other pharmaceutical manufacturers shall be considered coincidental due to the similarity of operations and the nature of the work. 

This book was designed and written for validation professionals responsible for writing and maintaining quality management systems for the successful operation of their companies. It provides a set of SOPs that can be used to manage and document critical validation and revalidation tasks in a pharmaceutical manufacturing facility. 

International Society for Pharmaceutical Engineering (ISPE) (2002), GAMP (Good Automated Manufacturing Practice) Guide for Validation of Automated System in Pharmaceutical Manufacturing, Version 4, ISPE. 

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