What is Regulatory Affairs In Pharmaceutical Industry:-
Regulatory Affairs (RA) is one of profession in pharmaceutical industry with great potential and opportunities , most of the pharma , biomedical ,companies in world have Regulatory Affairs department in their company. Regulatory Affairs profession in short can be described as process in a pharma company to collect, Analyze and Communicate the Benefits and the Risks and of a given Pharmaceutical or health care product to public as well as regulatory agencies all over the world.
Responsibilities of Pharmaceutical Regulatory Affairs (RA) involves collecting data , analyzing and preparing and presenting documents for registration to regulatory authorities and perform all subsequent dialogue to gain and maintain marketing authorization (MA) for the products Pharmaceutical or health care product.
Hence the Regulatory Affairs professionals are required to continue a track of every chang happening in the laws and legislations in the countries where a product is being marketed or a company is going to market its product.
Pharma Regulatory Affairs (RA) professionals not only do registration of pharmaceutical products, but they give an opinion to Pharmaceutical companies technically as well as strategically . They are involved right from right from development of a pharmaceutical product to manufacturing, marketing as well as post marketing studies . Advice of a regulatory Affairs on legal and technical requirements saves big money and time for a pharmaceutical company right from developing to the production and marketing the same.
Pharmaceutical Regulatory Affairs as Career:-
World over pharmaceutical industry is one of greatly regulated industry and there is great demand for peoples manages regulatory affairs.
Pharmaceutical Regulatory Affairs professionals have responsibility in following areas:
Pharmaceuticals industries were the first to be significantly regulated in the modern era.
In 1980 the European Community (European Union) started the regulation of health care products in the member countries. The concept of regulating medicines was well established in most member countries along similar lines to the US.
Pharmaceuticals and Health care or Pharmaceutical Regulatory Affairs Profession is still an emerging profession but has two major international professional membership societies:
The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine.
Pharmaceutical regulatory affairs is a field in pharmaceutical industry which has good scope as the personnel is trained all topics related to pharmaceutical manufacturing and its regulation in various countries.
The concern person is responsible for providing all technical data to pharmaceutical regulatory agency where he want to register the pharmaceutical product for sale, hence he must have knowledge
1. About Pharmaceutical Administration and Management,
2. How to Handling laboratory and manufacturing deviations
3. Pre approval inspections,
4. About Impact of Total Quality performance
5. GMP Certification and enforcement actions,
6.Maintenance and Update of Product Master Files ,
7.Internal Compliance of Documentation
8.Coordination and Assembling of CTD/eCTD,
9.Quality systems,
10.Quality Assurance,
11.Method Validations,
12.Process Validations,
13Master Validation Plan,
14.Protocols
15.Standard Operating Procedures (SOPs)
16.Auditing and Compliance Functions
17.Regulatory strategies
18.Regulatory agencies
19.legislation and documentation systems as required for USFDA, UKMCA/UKMHRA, MCC, WHO etc. , FDA/UKMHRA Queries and submission ,
20.Application requirements and guidelines ,
21.Electronic submissions ,
22.Medical device regulations ,
23.Stability as per ICH ,guidelines & MBRs; International harmonization , Practice of regulatory affairs,
24.USP, Pharmacological, Toxicological and Clinical Trial Information, Re-registration Documents Design,
25.Role of the International Business Operations of the Pharmaceutical MNCs in Attracting the FDI,
26.Clinical Pharmacy,
27.Drug Trials and Vaccine Trials Guidelines,
28.Drug Laws ,
30.IND training ,
31.How to Format, assemble and submit the NDA, Human Genetic Research,
32.Clinical Trials,
33.Indian Ethics Committee,
34.Good Clinical Practices (GCP),
35.Pharmaco-vigilance and ADR reporting ,
36.Clinical Trial Regulation,
37.Intellectual Property Rights,
38.Basis of Patentability,
39.Patent Application Procedure,
40.Compulsory License,
41.Infringement of Patents,
42.Product Registration for Regulated and Non Regulated Markets etc.
There are many agencies which offer course in Pharmaceutical regulatory affairs.
If you are a pharmacy graduate , and it is always advantages to enroll for a course which in teach you basic things about Pharma regulatory affairs in pharmaceutical industry for dealing with requirements of all countries.
There is good scope for Pharmaceutical regulatory affairs personnel for pharmaceutical industry , which is looking for registration of its products and selling its products in USA, Europe, and African countries , these activities require dedicated peoples and this activity is very important for pharmaceutical company, hence they pay good salaries to pharmaceutical regulatory affairs peoples.
we are providing some good documents to my fellow pharmacists working in regulatory affairs in pharmaceuticals manufacturing.
These will be very useful references for pharmaceutical regulatory affairs.
Validation of Cleaning process Master document sample
pharmaceuticals water system validation sample document
Water system validation sample document Purified water system DQ IQ PQ and actual validation document sample (Copy and paste in excel , in pasting option select match destination formatting)
Change control In pharmaceuticals master document as a sample 1st format
Installation qualifications of any machinery used in processing of pharmaceuticals manufacturing Change control format. second format
SOP for Microbiology (There are two sheets there copy and paste in excel , in pasting option select match destination formatting)
Sample Document of Installation Qualification of a pharmaceutical machinery
Pharmaceutical Product validation master plan.
Check list for inspection and Quality audit of your pharmaceutical manufacturing unit
CGMP guidelines will get detailed here
WHO GMP GUIDELINES ON GOOD MANUFACTURING PRACTICES (GMP) ON VALIDATION YOU WILL GET HERE
Amendments in US FDA CGMP guidelines on finished products Dec 2008 here is PDF
Here is a guideline document on quality by design
Guidelines for making a site master file of a pharmaceuticals manufacturing facility , a PDF guide is provided here this is a MHRA guideline , i feel this is a best guideline along with WHO guidelines for drafting site master file.
Here is a guideline document for Validations of pharmaceutical dosage form you can copy this and keep it for your reference in a word file.
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Pharmaceutical Validation