The GMP requirements for quality control / laboratory controls have been well defined for several years. Yet, audits and inspections frequently reveal mistakes in analytical testing, errors in analytical documentation, and shortcomings in managing of OOS / OOT results. Such deficiencies can have a severe impact on the release status of drug products. Where identified in an authority inspection, this can quickly escalate to costly consequences.
The reaction of the EU commission to revise the EU GMP guide (chapter 6) is ample evidence that GMP compliance in the area of Quality Control is still not a given in pharmaceutical companies today.
Through our work of interdisciplinary project consulting including international auditing / inspections, we constantly engage in the latest GMP requirements and their interpretation. As we keep our level of knowledge updated both from a regulatory and the practical perspective, we are able to provide You with effective support in implementing current and new regulatory demands.
Our support includes the following topics:
- Quality control organization and management
- Qualification, calibration and re-calibration of analytical instruments
- Validation of analytical procedures
- Transfer of analytical procedures
- Management of reference standards and reagents; stability of reference standards and reagents
- Sampling of starting materials, bulk and intermediates, sample management
- Processing of OOS and OOT results
- Concept drafting and administration of stability programs
- Training of quality control staff
- Auditing of contract laboratories