Good manufacturing practice principles

Self-inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures. 

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 

Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. 

Chapter 22 deals with general factory and hospital hygiene and the principles of good manufacturing practice (GMP) whieh if adhered to go a long w towards compormding the success of the processes deseribed in Chapters 17 and 20. 

Underwood E. (1998) Good manufacturing practice. In Principles and Practice of Disinfection, Preservation and Sterilization (eds A.D. Russell, W.B. Hugo G. AJ. Ayliffe), 3rd edn. Oxford Blackwell Scientific Publications. 

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. 

Principles of Good Manufacturing Practices for Bulk Pharmaceutical Excipients... 

HPLC precision is critical in pharmaceutical analysis.For most pharmaceutical assays under a good manufacturing practice (GMP) environment, retention time and peak area precision of <2.0% RSD must be demonstrated before any samples can be analyzed. This section reviews the fundamental principles of HPLC precision and offers practical guidelines for its enhancement. The reader is referred to Reference 18 for a more detailed treatment of this topic. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

The principles of good manufacturing practice should be applied to investigational medicinal products. 

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 result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

Guideline of the Commission for Principles of Good Manufacturing Practice for Medical Products, Directive 91/356/EEC, 1991. 

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