[PHARM 4] Drug Establishments

Pharmaceutical manufacturing

Pharmaceutical manufacturing

• Comprises physical processes such as blending, compression, filtration, heating, encapsulation, shearing, tableting, granulation, coating, and drying.

• Process of industrial scale synthesis of pharmaceutical drug by pharmaceutical companies.

drug outlet

• A drugstore, pharmacy, and other business establishment which sells drugs or medicines.

• Small scale

drug establishment

• Any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines.

• Large scale

drug manufacturer

• Establishment engaged in operations involved in the production of a drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labelling with the end in view of storage, distribution or sale of the product.

• Provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores and hospital pharmacies shall not be considered as production operations.

• Do NOT retail per blister

drug trader

• Any establishment that imports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other drug establishments or outlets.

• Do NOT manufacture their own

drug exporter

Any drug establishment that exports raw materials, active ingredients and/or finished products to another country

drug wholesaler

• Any drug establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis.

drug manufacturers

• Guidelines of cGMP

• Minimum standards for pharmaceutical manufacturing equipment/machines described in Annex A;

• If importing raw materials, active ingredients and/or finished products for use in manufacture of drug products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers.

• If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne by the applicant establishment.

drug traders

• Valid contract agreement with a BFAD-Licensed manufacturer containing a stipulation that both the drug trader and the manufacturer are jointly responsible for the quality of the product

• If importing raw materials, active ingredients and/or finished products for the use in the manufacture of drug products, a certificate that the manufacturer is registered with the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers.

• If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne by the applicant establishment

drug importers

• Foreign Agency Agreement between the Philippine importer and foreign supplier duly authenticated by the territorial Philippine Consulate.

• Certificate that the manufacturer of the raw material, active ingredient and/or finished product is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers

• If inspection of the foreign manufacturer is necessary, the cost of inspection shall be borne by the applicant establishment.

• In case of finished products, a Certificate of Free Sale of the products in the country of origin, duly authenticated by the territorial Philippine Consulate and evidence that such certificate is issued in substantial compliance with BFAD standards.

drug exporters

• A valid contract with BFAD-licensed manufacturer in addition to other requirements set by other competent authorities.

engineering research and development

Monitor the new trends developing in the marketplace and develop new products, upgrade the design of the existing products, do testing to understand the product functions

manufacturing systems engineering

• Team will be responsible to design the process for the manufacturing.

• Process that has to be adopted, design of tools and machines that are to be used, Inspection method that has to be practiced in an manufacturing process are decided by the MSE team.

• Product trails are done and once the product is proved to be capable after capabilities studies the process is handed over to the production team for mass production.

new products development

• They are responsible for the development of the product from the market inputs to development of the product and reaching the customers.

• Lead time in development of the product from idea to a product in real is the challenging task of the NPD team.

• Collab with ER&D

manufacturing department

• Involved in the conversion of the raw material to a finished product.

• Process plan is given by the MSE team and the manufacturing team does the manufacturing, assembly, inspection, packing of the products as per the process plan.

• Production of parts, assembly, testing and packing of the parts will be covered under the manufacturing Department.

quality department

• Ensures the proper deployment of the Quality management Systems that is in practice to ensure that the quality of the products produced are acceptable by the customer.

• Quality Management ensures Quality Planning, Quality assurance, Quality control and Quality improvements are practiced in the organization.

maintenance department

• Ensure the machines and equipment in the organization are in good working condition.

• Carries out various maintenance activities such as Preventive maintenance, break down maintenance, time based maintenance etc to keep the down time minimal in the organization.

marketing department

• Find out the need of the customer and fulfill the need with the products and services of the organization.

• This involves market research, setting prices, finding distribution channels, advertisements etc.

human resources department

• Ensure the Human resources in the industry are competent to perform the assigned activities.

• This involves Recruiting right people, training of existing people and motivating the people for the performance to improve their performance.

personnel department

• It ensures the people working in the industry are happy and safe.

• Meeting the safety measures, legal requirements and the welfare activities are the important function of the Personnel department.

finance department

• They acquire funds, and manage and re-distribute the funds based on the budget planned for the financial year.

• The Finance Department is responsible for the documentation of the assets in the organization.

• Finance departments process and monitor the revenue spending of the organization and ensure to keep them under the budgeted value.

pfizer

• immunology, oncology, cardiology, and neurology.

abbvie

• immunology, oncology and neuroscience.

johnson and johnson

• pharmaceuticals, medical devices and consumer health goods.

merck and co

• diabetes and cancer care

novartis

• innovative medicines, as well as generics and biosimilars.

roche

• oncology, immunology, infectious diseases, ophthalmology and neuroscience, and is split into two divisions: pharma and diagnostics.

bristol myers squibb

• oncology, hematology, immunology and cardiovascular disease.

sanofi

• specialty care, vaccines, and general medicines.

astrazeneca

• oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

gsk

• biologics, vaccines