Pharmaceutical Testing
Organisations and their Roles
Introduction The ultimate responsibility for the safety, quality and efficacy of medicines and medical devices lies with the various national regulatory bodies designated to
safeguard public health. In Europe, Japan and in the USA this function is performed by the European Medicines Agency (EMA) , the Ministry of Health , Welfare and Labor (MHWL) and the Food and Drug Administration (FDA) respectively. The regulatory authorities are supported in this role by the Pharmacopoeias whose job is to define the standards with which the drug formulation shall comply and the methods by which compliance will be adjudged. In October 1999, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)* published a single set of global specifications covering the Test Procedures and Acceptance Criteria for new drug substances and products . The guidance takes the form of a number of universal tests/criteria considered generally applicable to: a) new drug substances and b) new drug products together with a number of additional tests and acceptance criteria for specific substances and dosage forms, including solid oral drug products, liquid oral drug products and parenterals.
approach to pharmaceutical manufacturing. This initiative gave birth to Process Analytical Technology (PAT) , a framework for understanding and improving the processes involved in pharmaceutical development, manufacturing and quality control, described in FDA’s Guidance of September 2004. PAT operates on the premise that quality cannot be tested into products; rather, it should be built-in or by design. The goal is to ensure final product quality by understanding and controlling the processes involved in the manufacturing operation.
The additional tests for tablets (coated and uncoated) and hard capsules, for example, include: a) Dissolution b) Disintegration c) Hardness/Friability d) Uniformity of dosage units e) Water content and f) Microbial limits The guideline on quality concerned (Q6A) was subsequently agreed and adopted by all of the parties involved, including the EMA, FDA and MHWL. In 2002 the FDA launched a new initiative “Pharmaceutical cGMPs for the 21st Century” in which it proposed a new risk-based
* See Page 9 for further details
ICH Quality Guidelines Q1A - Q1F Stability
Q8 - Pharmaceutical Development
Q2 - Analytical Validation
Q9 - Quality Risk Management
Q3A - Q3D Impurities
Q10 - Pharmaceutical Quality System
Q4 - Q4B Pharmacopoeias
Q11 - Development and Manufacture of Drug Substances
Q5A - Q5E Quality of Biotechnological Products
Q12 - Lifecycle Management
Q6A - Q6B Specifications
Q13 - Continuous Manufacturing
Q7 - Good Manufacturing Practice
Q14 - Analytical Procedure Development
8
Powered by FlippingBook