Conclusions and the future of regulatory scrutiny

In this chapter, I have attempted to give an overview of the various QSs that are operated within the pharmaceutical industry. Some of these such as ISO 9000 and NAMAS are voluntary and are followed in order to give the company a competitive advantage. Others such as GMP and GLP are mandatory for any company manufacturing materials for human or veterinary use or who supply data to regulatory authorities on the safety of chemicals, whether in an R D or commercial environment. Hopefully, I have also tried to show that although the R D environment has different requirements with respect to quality from the commercial manufacture of pharmaceutical materials, quality is still a vital part of most R D s work. 

With respect to where quality and regulation are going, one needs to look at the way MRAs are being introduced between regulatory authorities worldwide. In an effort to control inspection and regulatory submission overheads, 

Good manufacturing guide for active pharmaceutical ingredients, ICH Q7A (November 2000). 

FDA guide to inspection of pharmaceutical quality control laboratories (22 June 1992). 

21 Code of Federal Regulations Part 11, Electronic Records, Electronic Signatures. 

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