Guide in this world for all unknowns!!

We enter this world as “clean slate”, and we need help and support before we stand alone or set our journey. Pigeons teach their young ones how to fly and return back to their place till the young ones learn how to fly and see the outside world. When we visit a new place to explore, we seek the help of the guide to learn about the history and about the place. If one wants to attain moksha / salvation, one definitely need spiritual guides.

Similarly, the world of Pharmaceuticals needs a guide of how to manufacture the drugs of the highest quality. So, there are guidances drafted and issued by regulatory agencies/authorities. There are regulations laid down and / or to be followed by each country for the drugs that are manufactured and distributed for medicinal use. One should know the guidances / regulations for drugs specific to that country. Serious lapses and deficiencies are observed later during the regulatory inspections and additional time/resources are needed later when they are found out.

Pharmaceuticals are considered as the most highly regulated industries world-wide. US and Europe are the highly regulated markets in the pharmaceutical industry. Regulations and guidances are issued by them. In many cases, the same topic is addressed in different guidances / regulations. Few regulations and guidances address topics in-depth and stringent and few are not so. There are regular updates to the regulations and guidances as an when required /demand arises / improvements etc.

Additionally, to note, Pharmacopoeia is a book describing drugs, chemicals and medicinal preparations issued by an officially recognized authority and serving as a standard. The term derives from ancient Greek “Making of medicine, drug-making”. A pharmacopoeia is a legally binding collection of standards and quality specifications for medicines used in a country or region. They help ensure the quality such as identity, strength and purity of medicines.

The various regulations and guidances are given according to different countries and requirements. This will serve as a simple guide to follow.

1.EMA – European Medicines Agency [European union]

Is an agency of the European Union [EU] in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency [EMEA].

2.MHRA-Medicines and healthcare products regulatory agency [United Kingdom]

Regulates medicines, medical devices and blood components for transfusion in the UK.

Guidelines-European Union-Eudra Lex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.

3.USFDA – United States Food and Drug Administration [United states]

The United States Food and Drug Administration [FDA or USFDA] is a federal agency of the Department of Health and Human Services

US–Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, September 2004 Pharmaceutical CGMP. US Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research [CDER] Center for Biologics Evaluation and Research [CBE] Office of Regulatory Affairs [ORA].

CFR-Code of federal regulations.

4.ICH-International Council for Harmonization

Founding Regulatory Members – Europe, United States, Japan in 1990. ICH topics divided into 4 categories – Q S E M [Quality, Safety, Efficacy and Multi-disciplinary guidelines].

5.ISO 14644 Standards

First formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The first document of ISO 14644-1 was published in 1999.  In 2000, ISO 14644-2 was published, which began the process of FED-STD-209E being cancelled. On November 29, 2001, the document was cancelled and superseded by ISO 14644-1 and ISO 14644-2.

6.PIC/S – Pharmaceutical Inspection Co-operation Scheme

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 countries-Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and United Kingdom. Membership of PIC was subsequently expanded to include Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia. Leading the international development, implementation and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products.

The Pharmaceutical Inspection Co-operation Scheme [PIC/S] was established in 1995 as an extension to the Pharmaceutical Inspection Convention [PIC] of 1970 by EFTA [European Free Trade Association] under the title of “The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. PIC/S aims at harmonizing 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 organizations, thus increasing mutual confidence.

7.PDA Parenteral Drug Association

Is an international non-profit industry trade group for pharmaceutical and biopharmaceutical manufacturers headquartered in Bethesda, MD, USA, with offices in Berlin, Germany, and Singapore.

The Parenteral Drug Association [PDA] is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community. For nearly 75 years, since its founding as a non-profit in 1946, PDA has been committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of our more than 10,500 members worldwide. 

PDA supports its mission to advance pharmaceutical and biopharmaceutical science and regulation so members can better serve patients by:

• Providing global forums for the scientific community, regulators, and industry professionals on emerging trends within the industry.

• Delivering unique, hands-on education and training courses through PDA’s manufacturing training facility.

• Fostering career-long learning and professional development.

• Encouraging scientific information sharing among industry peers.

• Serving as a leading contributor of information and expertise to influence global industry and regulatory solutions.

8.ISPE-International Society for Pharmaceutical Engineering 

The International Society for Pharmaceutical Engineering is the world’s largest not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals.

9.MCC-Medicines Control Council [South Africa]

As a participating authority of PIC/S, the MCC requires that manufacturers, importers and exporters of medicines and related substances in South Africa meet the standards laid out in the PIC/S Guide to Good Manufacturing Practice [GMP]. As such, the MCC has adopted the PIC/S Guide to GMP and all prospective adaptations as prescribed by the PIC/S.

10.TGA-Therapeutic Goods Administration [Australia]

Almost any product with therapeutic claims are made must be entered in the Australian register of Therapeutic goods [ARTG] before it can be supplied in Australia. The current Therapeutic Goods [Manufacturing Principles] specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice [GM] – 01 July 2018, PE009-14, except for its Annexes 4, 5 and 14 which are not adopted by Australia.

11.ISO 13485

Is an International Organization for Standardization [ISO] standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 [1993 and 1996] and EN 46002 [1996], the previously published ISO 13485 [1996 and 2003], and ISO 13488 [also 1996].

12.Medical Device Single Audit Program [MDSAP]

Therapeutic Goods Administration of Australia.

Brazil’s Agência Nacional de Vigilância Sanitária [ANVISA].

Health Canada.

Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency.

U.S. Food and Drug Administration.

Every life in this world needs a guide to know / learn correctly about the unknown things in life!

Muthu

Note-The images given for representation in this blog are taken from Google Images. Many thanks for Google.