Pharma ACTD Dossiers

Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned regulatory authority. In 1937, Elixir Sulfanilamide which was marketed without any marketing testing caused deaths of more than 100 people in the USA. The pharmaceutical company added DEG as a solvent along with raspberry flavor for Sulfanilamide to be used as an elixir. This created an outrage and finally, led to the Federal Food, Drug and Cosmetic Act in 1938. However, the tragic incidents did not end there, there were many which led to various acts and amendments and one of the impactful ...

Certificates of Analysis (CoA) World’s future of business is in outsourcing and globalisation EU GMP Guide Part I (Chapter 4 and Chapter 6) - these chapters contains detailed information about safety and quality, Laboratory documentation should follow the principles given in Chapter 4. EU GMP Guide Part II - Section 11.4 – §         Authentic Certificates of Analysis should be issued for each batch of intermediate or API on request. §         Information on the name of the intermediate or API including where appropriate its grade, the batch number, and the date of release should be provided on the Certificate of Analysis. For intermediates or APIs with an expiry date, the expiry date should be provided on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis. §  ...

In general,  compliance  means conforming to a rule, such as a specification,  policy , standard or law.  Regulatory compliance  describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources. Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry, and the Joint Commission and HIP...

Counterfeiting A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source.  Counterfeiting of medicines can apply to both branded and generic products. Generally, counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with in correct quantities of activities ingredients or with fake packaging  Counterfeit Medicines Products marketed with intent to deceive 1– Counterfeit active/bulk ingredients 2– Counterfeit finished products 3– Unregulated diverted products 4– Counterfeit labeling 5– Mislabeled substances (e.g., generic anti-biotics) Why are Medicines a Target? Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk). Many countries, especially in the developing world lack adequate regulation and enforcement Even in the industrialized countries, the risk of ...

South Africans need to return 318,000 packets of potentially dangerous pills The South African distributor of heart pills that may contain a potentially carcinogenic ingredient has confirmed that more than 318,000 packets of pills may be affected. “Operationally, it is a difficult situation,” a representative of Pharma Dynamics, the distributor of the tablets in South Africa, told Business Insider South Africa. The South African Health Products Regulatory Authority (SAHPRA) this week recalled Dynaval Co high blood pressure and heart pills, which may contain a controversial carcinogenic ingredient that was manufactured in China. Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg pills, which were manufactured by Zhejiang Huahai Pharmaceuticals, may contain the chemical NDMA. NDMA is associated with liver damage and liver cancer in rats as part of laboratory tests, says dr Eric Decloedt, a clinical pharmacologist at the department of medicine of the University of St...

Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission. Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations. Medical and Clinical Consulting Consulting on the Complete Product Development Program (all phases) Reviewing and Assessing Clinical Protocols Reviewing Safety and Efficacy Related Issues During Product Development Adjudicating Clinical Data Worldwide Drug Safety and Pharmacovigilance Services Clinical Trial Safety Services Post-Marketing Surveillance Services Pharmacovigilance ...

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent. Good documentation practice  (commonly abbreviated  GDP , recommended to abbreviate as  GDocP  to distinguish from "good  distribution  practice" also abbreviated GDP) is a term in the  pharmaceutical and medical device industries  to describe standards by which  documents  are created and maintained. What to write, and how to GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FD...