PQG publications
The PQG monograph and PS9000 series have been carefully created by some of the most experienced people in pharmaceutical quality to provide a set of authoritative guides. The monographs are a ready source of primary data and cross-referenced material to help make pharmaceutical professionals’ method, protocol or standard operating procedure development more effective.
PQG Monographs
These monographs will be of particular interest to management and supervisory personnel engaged in the manufacture and supply of medicines, especially where they are involved in the training and education of staff.
Currently available monographs are:
- Pharmaceutical Auditing
- Cleaning Validation
- Pharmaceutical Packaging Validation
- Pharmaceutical Premises and Environment
- Pharmaceutical Manufacturing (Processing and Packaging)
- Elements and Philosophy of Pharmaceutical Quality Assurance
- Pharmaceutical Distribution
- Contract Manufacture And Analysis
- Pharmaceutical Documentation
- Good Control Laboratory Practice
- Microbiological Control for Non-sterile Pharmaceuticals (new March 2009)
PS 9000 Series for suppliers to the Pharmaceutical Industry
These standards are of particular interest to management and supervisory personnel engaged in the manufacture and supply of excipients and packing materials, especially where they are involved in the training and education of staff.
The series currently contains the following documents:
PS 9000:2001
This is an application standard developed by the PQG for the manufacture of packaging materials for medicinal products. The document defines specific requirements and guidance for GMP integrated with ISO 9001.
PS 9004 Pharmaceutical Packaging Materials – A Guide to PS 9000.
The guide provides in clear language, the appropriate reason for each critical requirement contained in PS9000:2001 together with details of sources of further useful reference information. The guide is intended primarily to help with the education and training of supplier's staff but will also be useful for the training of appropriate pharmaceutical industry staff.
PS 9100
PS 9100:2002 is an application standard developed by the PQG for the manufacture of excipients for medicinal products. This code of practice defines specific requirements and guidance for GMP integrated with ISO 9001.