Why Documentation of Regulatory processes is must?

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What is Documentation?

Documentation is material that provides official information that serves as a record. This record may be used for legal issues, during audits, visits of regulatory authorities and for office.

Documentation can be defined as:

Documentation is a set of documents provided on paper, online or on digital .

What are different Forms of Documentation?

Documentation is usually done manually on the normal papers used in offices. Now there is era of computer and documentation is also done on electronic sheets within the computer.

Is documentation present for all Drugs laws and regulatory matters?

The report of WHO (World Health Organization) about; A multicounty study for effective drug regulation shows that not all drug regulatory authorities provide documentation for standard procedures for registration and few are the authorities that provide and can show documented guides and checklist for inspection. This is not a positive sign. Due to this problem there may come variation in the implementation of laws and such other policies or procedures. This thing also creates a question about the transparency of law governance. In European countries and American states there is tried to continuously update and document procedures, policies and laws. There is severe need to establish policies and procedures in written form for all regulatory issues and matters.

Is documentation necessary about regulatory matters of Pharmaceuticals and Drugs?

According to US FDA and other health agencies documentation is must for all regulatory matters. This documentation can be from FDA itself, in manufacturing units, Suppliers, Distributors and even at Pharmacies or medical stores level. This is requirement of Ministry of Health and other major agencies of European countries, Saudi Arabia, China, Pakistan and other countries. Remember, the Pharmaceutical field has very much sensitivity as compared to other consumer areas. Documentation is also necessary by other industries like oil, soaps, creams and others but Pharmaceutical industry has its own importance, care and safety.

About what regulatory matters there is required Documentation?

Before I give detail about regulatory matters where there is need of documentation, I want to tell that Pharmaceutical laws and regulations are very necessary. If Drugs will be ineffective, low quality and harmful, they will cause failure at therapeutic level and may cause deaths in some cases. That is the reason the Government needs to apply, improve and implement laws and regulations for the public health and the growth of society.

Now regulatory matters whose documentation is must for FDA, Pharmaceutical industry, distributors and pharmacies are discussed here. This is regulatory requirement that all regulatory Laws should be clear and in documentation so that the health professionals, pharmacists and public can understand and apply in their respective areas according to conditions. At industry level there must be documentation according to Batch number being used in different times along their manufacturing date, expiry date, Manufacturing retail and trade price, weight of active ingredients and temperature condition etc. There should be documentation about product name, active ingredient of Drugs, potency, weight, labeling around the bottles or strips or injections and also on the outer side of big cartons etc. Similarly, at industry, supplier and distribution level there is must to keep document, s record about Batch number, manufacturing and expiry dates, prices, temperature control figures according to room temperature, AC Room and refrigerators, temperature control of cool chain products, shipping and logistics of these products through special vehicles in ice coolers by using ice packs and such other devices. Logistics of Drugs from industry or distribution setup according to information given on the related invoice and such other regulatory aspects.

References:

http://apps.who.int/medicinedocs/pdf/s2300e/s2300e.pdf

http://water.epa.gov/scitech/wastetech/guide/upload/unuseddraft.pdf

http://apps.who.int/medicinedocs/documents/s19583en/s19583en.pdf

https://www.gov.uk/medicines-packaging-labelling-and-patient-information-leaflets

http://www0.health.nsw.gov.au/policies/pd/2013/pdf/PD2013_043.pdf

http://www.webopedia.com/TERM/D/documentation.html

http://en.wikipedia.org/wiki/Documentation

About the Author

Anjum Rehman's picture
Author: Anjum Rehman

I am an experienced Pharmacist and MBA.

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