Lecture 1: Overview of Pharmaceutical and Industrial Pharmacy Regulation PDF

Overview on regulation of pharmaceuticals and industrial pharmacy Dr. Md. Shalauddin Module: PFD-1 Date: 23.09.24 Venue: LT-11  Learning objective  Overview of Regulation of Pharmaceuticals Sometimes also known as drug regulation  Overview of Industrial Pharmacy Prac...

Overview on regulation of pharmaceuticals and industrial pharmacy Dr. Md. Shalauddin Module: PFD-1 Date: 23.09.24 Venue: LT-11  Learning objective  Overview of Regulation of Pharmaceuticals Sometimes also known as drug regulation  Overview of Industrial Pharmacy Practice issues in the industry  regulation What is it? Pharmaceutical regulation involves the laws, guidelines, and rules set by governmental and international agencies. How does it help us? To ensure the safety, efficacy, and quality of pharmaceuticals. These regulations cover every aspect of drug development, manufacturing, marketing, and post-market surveillance. Example: The U.S. Food and Drug Administration (FDA) regulates the pharmaceutical industry in the United States. Before a new drug can be marketed, it must go through a rigorous approval process that includes preclinical studies, clinical trials, and review of the manufacturing process.  Regulation of Pharmaceuticals Why regulation is needed? Patients and prescribers must have access to safe and effective medicines. Industry and Academia must have a clear understanding of what is required. Governments must decide whether the benefits of a drug outweigh their potential risks.  Which area are regulated? Marketing Authorizations license for “marketing authorization” for a particular product. Clinical Research Investigational New Drug Applications (INDs) and clinical Trial Application (CTAs) are assessed by regulatory authorities in order to ensure the safety of trial subjects, suitable quality of the product and the reliability of results. Pharmacovigilance All sponsors are required to have a robust pharmacovigilance system in place to ensure that the safety of its products are monitored, and any Roles of RA potential safety issues are monitored and investigated.  Regulatory Authorities Country/ Continent Regulatory Authorities International ICH (International council for Harmonization) WHO ( World Health Organization) Europe EMEA(European Medicine Evaluation Agency) US USFDA (United States Food and Drug Administration ) UK MHRA (Medical and Healthcare Products Regulatory Agency) Australia TGA (Therapeutic Goods Administration ) China SFDA ( State Food and Drug Administration) Brazil National Health Servilance Agency(NHSA) New Zealand The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) Malaysia The National Pharmaceutical Regulatory Agency (NPRA),1984  Overview of major regulatory bodies ICH (International council for Harmonization of Technical Requirement of pharmaceuticals for Human use, launched in 1990 by US, EU, and Japan. It is a unique harmonization organization involving regulators and the pharmaceutical industry. The United States Food and Drug Administration (USFDA) was founded in 1906 in the United States Department of Agriculture (USDA). It was later reorganized and renamed the Food, Drug, and Insecticide Administration in 1927, and then renamed again as the Food and Drug Administration in 1930. The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health(1989), and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.  What is drug regulation? Drug regulation is the process by which- Government Regulatory Agency Supervise Development Approval Production Distribution Step-1 Monitoring of PP in Market Step-2 The main objectives of drug regulation are to ensure that medications are safe, effective, and of high quality, and to protect public health.  Key components of drug regulation 1. Pre-Market Approval: Before a drug can be marketed, it must go through a rigorous evaluation process, which is involved with preclinical testing (laboratory and animal studies) and clinical trials (studies on humans) to gather evidence of the drug's safety and efficacy.  Key components of drug regulation 2. Quality Control: Regulations set standards for the manufacturing processes, ensuring that drugs are consistently produced with high quality. This includes Good Manufacturing Practices (GMP), which cover everything from the cleanliness of the facilities to the training of staff. 3. Labeling and Advertising: Drug labels must include accurate information about the drug's uses, dosage, side effects, and warnings.  Key components of drug regulation 4. Post-Market Surveillance, after a drug is approved and available on the market, need to continues monitoring for the analysis of adverse effects. 5. Enforcement and Compliance: Regulatory agencies need to conduct regular inspections, issuing recalls, and taking legal action if necessary. 6. Generic Drugs and Biosimilars: Regulations also cover the approval and monitoring of generic drugs (which are equivalent to branded drugs) and biosimilars (which are similar to biological drugs).  How do you know if the product is registered? In many countries, illegal medicine is a problem. Counterfeit medications, also known as fake medications, are defined as medicines that have been fraudulently produced or packaged; they do not contain any active ingredient or contain the wrong quantities. How do you know a product is registered in Malaysia? Following steps are involved to check the Pharmaceutical product registration in Malaysia. 1.Visit the National Pharmaceutical Regulatory Agency (NPRA) Website and Search Registered Products and checked the product by its name, registration number, active ingredient, or manufacturer. 2.Checking for a Registration Number, a unique registration number that starts with "MAL" followed by an 8-digit number (e.g., MAL12345678). or 3. Consulting a Pharmacist, if a product is registered to verify. 4. Check the Hologram, which is an additional indication that the product is authentic and registered.  MAL : MALAYSIA 12345678 : 8 NUMBERS  A :- Controlled medicine  X :- (OTC) Over the counter medicine  T :- Traditional Medicines  N :- Supplements Hologram  Basis of Marketing Authorisation Safety, Efficacy and Quality Regulatory Agency approves a Regulatory Agency Approval: medicine based on safety, efficacy, and quality. "Industry prepares the application Industry Application Preparation: based on safety, efficacy, and quality." Guidelines: Specific guidelines for safety, efficacy, and quality." Regulatory Pharmacists submit Regulatory Pharmacists the application to the Submission: Regulatory Agency. Regulatory Pharmacists at the Evaluation Agency evaluate the application.  What does a pharmacist do in Regulatory Department in Industry? Role of a Pharmacist in the Regulatory Department Plays a central Role in Drug Development New Drug application (NDA) Preparation : After Phase 3 Clinical Trials, Documentation for Submission. Communication with Regulatory Agencies: Answering Queries, Ensuring Compliance Post-Registration Activities: Ongoing Monitoring after product is registered. Internal Communication: Collaborating with Plant Personnel regarding regulatory issues Other Regulatory Activities: Promotion and Advertising Compliance. What are the regulatory pharmacy lectures in this module? Regulation of pharmaceuticals: Introduction to drug regulation Elements of drug regulation Regulatory control during product development and marketing authorization Industrial Pharmacy  Industrial Pharmacy Industrial pharmacy is the discipline of pharmacy that deals with the manufacturing, development, marketing, and distribution of drug products, including quality control and assurance. It focuses on transforming a chemical entity into a safe and effective drug product. The production of a tablet involves multiple steps such as blending of active ingredients with excipients, granulation, drying, compression, coating, and packaging. Each step must comply with Good Manufacturing Practices (GMP) to ensure product quality and safety. Industrial Pharmacy  There are 3 lectures on Industrial Pharmacy in this module  Malaysian Pharmaceutical Industry  Good Manufacturing Practice in pharmaceutical manufacturing industry  Important industry practices in pharmaceutical manufacturing  Industrial Pharmacy The focus is on Local Pharmaceutical Manufacturing Industry, Some understanding of local pharmaceutical manufacturing industry  Possibility of a career in the local pharmaceutical manufacturing industry  Good manufacturing Practice-Why is this knowledge important? What you will know as a pharmacy graduate: Formulation activity, Tableting Technology, Sterile products, Quality control tests and Others What knowledge is required to work in a manufacturing plant?  What is Industrial Practice Knowledge? It includes knowledge of manufacturing processes, quality control, regulatory compliance, and safety standards Major Components of IP: Technical Skills like tools, equipment, and technologies used in the industry. Knowledge of laws and regulations governing the industry ( Regulatory Compliance) Quality Assurance is ensuring products meet defined quality standards. Identifying and resolving issues that arise during industrial operations (Problem-Solving) Benefit of practice Streamlines processes make sure the smooth running, reduces waste. Ensures safe working environments. Keeps companies ahead in the market.  Manufacturing environment  Manufacturing environment has unique properties and the total area are specialized areas.  Some examples  Understanding of all the various departments  The role of each department  Good manufacturing Practice-Why is this knowledge important?  It is a controlled environment-What does this mean?  All activities are strictly governed by SOPs Take an example of tableting process  Some practical examples  Contamination issues 1. Product contamination 2. Cross contamination How do you avoid contamination?  Validation 1. Process validation 2. Analytical validation 3. Equipment Validation  HVAC  Water  Contamination are key concepts in pharmaceutical manufacturing and quality control: 1. Product Contamination refers to the presence of undesirable substances—such as microorganisms, chemicals, or foreign particles—can arise from various sources like personal, equipment and raw materials, in a product, which can compromise its safety, efficacy, or quality. Contamination can occur at any stage of production, from raw materials to packaging, and poses significant risks to patients. 2. Cross-Contamination occurs when one product contaminates another during manufacturing or handling. It often happens when different products are made in the same facility without proper cleaning or separation. Its may be direct and indirect. Both must be controlled through stringent Good Manufacturing Practices (GMP) to ensure product safety.  HVAC  HVAC system (Heating, Ventilation, and Air Conditioning) in pharmaceutical facilities is crucial for maintaining controlled environments that ensure product quality and compliance with regulatory standards. Key functions include: 1. Temperature and Humidity Control for manufacturing and storage of sensitive pharmaceutical products. Temperature-20-25◦C, Humidity- 30-60% 2. Air Filtration: Uses HEPA filters to remove contaminants (e.g., dust, microorganisms) and maintain cleanroom standards. 3. Pressure Control, maintains positive or negative pressure to prevent cross- contamination between different manufacturing areas. 4. Airflow Management, provides a continuous supply of clean air and helps in the removal of contaminants from the production environment. Well-designed HVAC system is essential for meeting Good Manufacturing Practices (GMP) Pharmaceutical water system  For all the pharmaceutical manufacturers, a water system is critical for producing high-purity water required for drug formulation, cleaning, and other processes. Key types of water include: 1. Purified Water (PW): Used in non-sterile manufacturing, produced by - reverse osmosis, deionization, or distillation process 2. Water for Injection (WFI): Sterile water used for injectable drugs, requiring a higher level of purity, typically produced by distillation or reverse osmosis. 3. Ultra-Pure Water: Often used in specific high-purity applications, including biotechnology.  Pharmaceutical water systems must prevent contamination and microbial growth, employing Good Manufacturing Practices (GMP) with regular monitoring of water quality, sanitation, and maintenance.  Reference J Eilbeck, G Rowley, P.A Carter, E.J Fletcher, Effect of contamination of pharmaceutical equipment on powder triboelectrification, International Journal of Pharmaceutics, Volume 195, Issues 1–2, 2000, Pages 7-11, Williams RT, Cook JC. 2007. Exposure to pharmaceuticals present in the environment. Drug Inf J 41:13 Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig Lippincott Williams & Wilkins, 1986 - Medical - 902 pages 3–141.