Meeting updated quality standards

New pharma codes of practice integrate GMP/GLP with ISO9001/2, and Fred Baker Scientific has changed its methods to comply

Established by the Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA), the new PSCOP Codes of Practice, in conjunction with ISO 9001/2, integrate the principles of good manufacturing practice (GMP) and good laboratory practice (GLP) for suppliers of raw materials (active ingredients and excipients) to the pharmaceutical industry. It ensures that suppliers' products and methodologies conform to the same stringent standards of GMP and GLP that apply throughout the pharmaceutical manufacturing process.

The PQG lists 66 companies that meet the requirements against one or more of the three Codes of Practice. Less than 10 of these are IQA/PQG-certified suppliers of raw materials for the pharmaceutical industry.

Pharmaceutical manufacturers are constantly monitored by the UK Medicines Inspectorate and need to be fully GMP-compliant in order to be licensed to manufacture and distribute goods as pharmaceutical suppliers to consumers. However, suppliers to the pharmaceutical industry follow full GMP/GLP guidelines but are not regulated by the Medicines Inspectorate as they do not manufacture pharmaceuticals.

One company that has successfully made the transition from ISO 9001 to PSCOP certification is Fred Baker Scientific. Tony Harper of Pharmaceutical Technology Consultants played a key role in ensuring the transition ran smoothly. Companies must seek certification from an Accredited Certification Body that is government-recognised through UKAS (UK Accreditation Service). Harper worked with the company to assist in meeting the requirements of the PSCOP scheme, that is now over 10 years old, and supported the subsequent recommendation for certification.

'Although the company already had the ISO 9001 standard, this Code of Practice covers additional particular requirements and covers the GMP elements that the pharmaceutical industry demands from its suppliers,' he explained.

raw materials codes

Fred Baker Scientific has been audited against the PSCOP in relation to the manufacture of raw materials (active ingredients and excipients) used by pharmaceutical manufacturers in the preparation of medicinal products. Two other codes are for the manufacture of printed materials for use in the packaging and labelling of medicinal products, and the manufacture of medicinal product contact packaging materials.

The decision to upgrade to PSCOP has resulted in certification to a GMP-recognised standard that satisfies the requirements of the pharmaceutical industry, which needs to be able to control its suppliers. This is of mutual benefit to both suppliers and pharmaceutical companies, for the assurance and guarantee that their products meet the highest standards.

John Cobb, director of quality assurance at Fred Baker Scientific, says, 'We are committed to a process of continuous improvement and have always responded quickly to the ever increasing technical demands of our customers. Conforming to the stringent quality requirements dictated by the Code of Practice is a natural progression for the company and strengthens our position in the pharmaceutical industry.'

PSCOP is necessary to ensure that the ultimate customers, the patients, receive medicines of the highest quality and consistency. Pharmaceutical Quality Group guidelines describe how 'experience has shown that appropriate controls need to be extended to the industry's suppliers to guarantee this quality, as inspection on receipt is not always failsafe'. The guaranteed high standards of goods supplied to the pharmaceutical industry are essential as 'quality products can only be delivered to the customer if quality is built in right from the beginning of the process. Since the process begins with the supply of good quality material and packaging, companies in the pharmaceutical industry need to be confident that their suppliers are also fully committed to this concept'.

During the transition from ISO 9001 to PSCOP, a standard-operating-procedure-driven quality system was implemented, covering all aspects of the business from warehouse, service department and production sites to customer services and accounts.

Following significant investments in the manufacturing facilities to comply with PSCOP, a Class J — BS5295/Class 7 — ISO 14644 cleanroom now houses state-of-the-art preparation and pouring technology, which incorporates Class 100 filtered air at the filling points. All batches of media are supplied with full traceability and certification for performance and sterility, and γ-irradiated triple wrapped media are available in three formats, 140mm, 90mm and 55mm contact plates, in addition to single wrapped non-irradiated media.