Unit 1B Pharmaceutical Manufacturers PDF

PHARMACEUTICAL MANUFACTURERS Accdg to RA 10918: Pharmaceutical manufacturers refer to establishments engaged in any or all operations involved in the production of pharmaceutical products including the preparation, processing, compounding, formulating, f...

PHARMACEUTICAL MANUFACTURERS Accdg to RA 10918: Pharmaceutical manufacturers refer to establishments engaged in any or all operations involved in the production of pharmaceutical products including the preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeling, preparatory to their storage, sale, or distribution, except the compounding and filling of prescriptions in pharmaceutical outlets TYPES: 1. Big Pharma companies These are giants in the industry, have various divisions, and product range includes drugs for different conditions- both prescription and OTC. They heavily invest in in R&D to discover new molecules and bring new drugs to the market. They also spend lots of money on marketing to ensure that their products get maximum exposure. 2. Generic manufacturing companies These companies produce generic versions of existing drugs that are no longer under patent protection. Generic manufacturing companies compete on price, and their products are usually substantially cheaper than the brand-name versions. These companies do not invest in R&D, and their main focus is manufacturing and distribution. Generic manufacturing companies have a significant volume of sales, mainly because they produce a broad range of products. However, they operate at very slim profit margins due to competing on price and mass production. https://www.ritemed.com.ph/our-history 3. Specialty Pharm companies They focus on developing drugs and therapies for specific conditions such as rare or chronic diseases. They are relatively new compared to generic or big pharma companies and are experiencing rapid growth driven by the number of people living with rare or chronic conditions. Their products are expensive hence have a comparatively higher profit margins than generic manufacturers. The Specialty Pharmaceuticals Market is Segmented by : 1. Therapeutic Area (Oncology, Inflammatory Conditions, Multiple Sclerosis, Infectious Diseases, and Others (Women's Health, Growth Hormone, and Respiratory)) 2. Route of Administration (Oral, Parenteral, and Transdermal), 3. Distribution Channel (Hospitals, Retail Pharmacies, and Specialty Pharmacies) 4. Geography (North America, Europe, Asia Pacific, Middle-East and Africa, and South America). Source: https://www.mordorintelligence.com/industry-reports/specialty-pharmaceuticals-market 4. Contract manufacturing organizations/ Third party manufacturers These companies provide manufacturing services to other pharmaceutical companies that develop drugs and therapies. Contract manufacturing organizations take on the responsibility of manufacturing, packaging, and distributing drugs. Contract manufacturing organizations are usually preferred by small pharmaceutical companies that cannot afford to build and operate their own facilities. Contract manufacturing organizations can also be beneficial for large pharmaceutical companies that need a specific molecule to be manufactured in one of their facilities while they concentrate on R&D. Benefits: 1. Cost savings = can come from reduced labor costs, shared overhead costs and investments in facilities and equipment 2. Quality control = contract manufacturers are experts in their fields with necessary knowledge and equipment to endure high quality of products 3. Production efficiency = can face production demands as they produce in large quantities 4. Focus on core competencies = allows mother companies to save money and allocate more resources to research, marketing and other aspects of their business. 5. Intellectual property protection = Clear provisions regarding IP protection an be included in the agreement to ensure that all proprietary information are secure. Non-Disclosure Agreement (NDA) is a legally binding document that safeguards sensitive and proprietary information to protect intellectual property, trade secrets, and confidential data about the process/ production 6. Risk mitigation = contract manufacturers can mitigate risks associated with inventory costs, market fluctuations, and unpredictable changes in demand to adjust production quantities as needed, avoiding excess inventories or stock shortages, 7. International expansion = Contract manufacturers with global operations can provide insights and support for expanding business overseas. 8. Marketing strategies = allows flexibility to explore various marketing strategies without being tied to the limitations of in- house production, leading to a more agile and adaptable market approach. 9. Outsourcing production for smaller companies= beneficial when competing against larger and more established manufacturers 10. End-to-end manufacturing services = Offers a comprehensive approach that simplifies the manufacturing process encompassing everything from raw materials procurement to final product assembly Disadvantages: 1. Loss of complete control being shifted to contractors 2. Limited influence on production decisions that may be different from the specific preferences or requirements of the motehr company 3. Service subcontractiing of contract manufacturers leading to potential complications in QC and supply chain transparency 4. Overhead costs associated in managing the relationship can impact the overall financial benefits https://www.unilab.com.ph/our-commitment-to-quality 5. Research and Development Companies These companies are focused on the research and development of new drugs and therapies. They invest heavily in R&D to find new molecules, conduct clinical trials, and obtain regulatory approval for their products. Research and development companies are usually small biotech startups that get acquired by larger companies at different stages of development. Developing a new drug takes several years and can cost billions of dollars. Therefore, only a few of these companies are fortunate enough to develop a product that reaches the market.  PLANT CONSIDERATIONS LOCATION - Premises located to minimize cross- contamination - Free from geographical disturbances such as earthquakes - Non flooded area DESIGN - It is important to understand the manufacturing processes and conduct a facility programming. The layout must be an integrated design that satisfies the following: o Process requirements o Personnel flow o Material flow o Equipment layout requirements o Operational access requirements o Maintenance access requirements o Designed/ constructed/ maintained according to CGMP, WHO and FDA requirements IMPORTANT: The following aims must be met, relative to space, provisions and equipment: 1. Adequate product quality 2. Acceptable working conditions 3. Manufacturing efficiency DEPARTMENTS IN A PHARMACEUTICAL PLANT SALES DEPARTMENT aka Marketing Department Objective: To maximize or increase the turnover of drug products Responsibilities: 1. Consumption of finished products 2. Promotion 3. Conduct of medical conventions, seminars, product launch, symposiums, etc 4. Survey of the sales market 5. Design of the package, container and input on the DF design as preferred by customers Considerations: 1. is the product acceptable? 2. Is there already an existing product similar to it? 3. What is the advisability of a new drug/ version? PRODUCTION DEPARTMENT Objective: To produce the right amount of products at the right time, at the right conditions Sections: 1. Procurement 2. Storage Area 3. Production Area 4. Production QC Area 5. Packaging section 6. Shipping docks QUALITY CONTROL Objective: Responsible for sampling, specification and testing; ensures that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory; equipped with adequate facilities, trained personnel and approved procedures Responsibilities: 1. Sampling by QC personnel and testing using approved methods to ensure ingredients comply with regulatory specifications ( grade, composition, strength) 2. Maintenance of QC records and failure investigation records 3. Assessment of process deviations 4. Release of batches by authorized person 5. Environmental monitoring ENGINEERING DEPARTMENT Objective: To assist other departments Responsibilities: 1. Location, installation and maintenance of equipment, machines, electrical devices and other apparatus 2. Plant operation services ( ie water, air, steam, air conditioning, temp control, humidity control) 3. Ground setting and maintenance 4. Environmental hazard elimination PURCHASING DEPARTMENT Responsibilities: 1.Sourcing and Buying of materials, supplies and equipment; requires “On site inspections” of supplier facilities 2. Checking of incoming materials 3. Accounting 4. General Inventory 5. Public Relations with suppliers RESEARCH DEPARTMENT (OPTIONAL) Objective: To undertake investigational work in various fields of pharmaceutical interest, like Pharmaceutical research Radioactive Research Chemical Research Epidemiological Research Physical Research Pharmacological research WAREHOUSE Objective: to temporarily hold/ store properly segregated, identified and labeled materials; incoming and outgoing docks Important: To retain stability of materials ( raw, packaging, bulk, intermediate, finished and rejected), proper storage conditions as required by each material should be followed MISCELLANEOUS 1. Medical Department = Responsibilities: 1. Treatment of all sick employees 2. Medical examination for all employees and applicants 3. Preparation of drug inserts 4. publications 5. Work with R&D on clinical trials 6. Research 2. Regulatory Affairs= For FDA registrations of products; monitors legislations and regulations affecting the company and its products TYPICAL SUPPLY CHAIN OF A LOCAL DRUG COMPANY ASSIGN: RESEARCH ON THE PHARMACEUTICAL SUPPLY CHAIN (definition, importance, steps, challenges and innovations) https://www.researchgate.net/publication/241764839_A_Profile_of_the_Philippine_Pharmaceutical_Sector/figures?lo=1