There are different regulatory guidelines in the pharmaceutical industry but the major guidelines which are in practice are as follows:
US Regulation
In the US, the regulatory standard for human pharmaceutical products is the Current Good Manufacturing Practice regulations, which are enforced by the FDA.
- The FDA inspects manufacturers worldwide for compliance with CGMP.
- The FDA issues guidance for manufacturers in the Code of Federal Regulations, Current Good Manufacturing Practice for Finished Pharmaceuticals.
- These guidance documents do not bind companies to follow them and an alternative approach is acceptable if it fulfils the requirements of the regulations.
EU Regulations
EU regulations require all pharmaceutical manufacturers to comply with EU Good Manufacturing Practices (GMPs) if they want to supply products to the EU.
- Manufacturers and importers must be authorised and registered by a competent authority from a member state.
- Manufacturers and importers are regularly inspected by an EU competent authority or other approved authority to check compliance with the EU GMPs. This applies wherever the manufacturer is located.
- The frequency of inspection is based on a risk assessment and in addition the local national competent authority must supply written confirmation that each batch of product conformed to GMPs.
- Where products are imported by a separate company the importer is responsible for ensuring compliance with GMP.
The EU legislation governing pharmaceutical products is compiled in the publication “The rules governing medicinal products in the European Union”.
In addition, the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe (separate from the EU and EC), which is responsible for the European Pharmacopoeia, can also inspect manufacturers and issue Certificates of Suitability that can replace most of the data in the EU Marketing Authorisation of medicines.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH’s has achieved greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.
With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015, ICH’s mission has been embodied.
Stability Testing of New Drug Substances and Products
Stability Testing : Photostability Testing of New Drug Substances and Products
Stability Testing for New Dosage Forms
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
Validation of Analytical Procedures: Text and Methodology
Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Residue on Ignition/Sulphated Ash General Chapter
Test for Extractable Volume of Parenteral Preparations General Chapter
Test for Particulate Contamination: Sub-Visible Particles General Chapter
Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Disintegration Test General Chapter
Uniformity of Dosage Units General Chapter
Dissolution Test General Chapter
Sterility Test General Chapter
Tablet Friability General Chapter
Polyacrylamide Gel Electrophoresis General Chapter
Capillary Electrophoresis General Chapter
Analytical Sieving General Chapter
Bulk Density and Tapped Density of Powders General Chapter
Bacterial Endotoxins Test General Chapter
Frequently Asked Question
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Quality Risk Management
Q8/Q9/Q10 – Implementation
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Training on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management
Continuous Manufacturing of Drug Substances and Drug Products
Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system.
PIC/S presently comprises 53 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).
PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
Schedule M is a part of Drug and Cosmetic act 1940. It is GMP for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.
