M1 Intro to Manuf Pharmacy PDF

Module 1 Introduction to Manufacturing Pharmacy Lesson 1 Concepts of Pharmaceutical Manufacturing b. Filipino-Owned Companies Pharmaceutical Establishments United Laboratories (along with its subsidiaries namely Asian refer to ent...

Module 1 Introduction to Manufacturing Pharmacy Lesson 1 Concepts of Pharmaceutical Manufacturing b. Filipino-Owned Companies Pharmaceutical Establishments United Laboratories (along with its subsidiaries namely Asian refer to entities licensed by appropriate government agencies, Antibiotics, Amherst, and Westmont) and which are involved in the manufacture, importation, Pascual Laboratories AM-Europharma exportation, repacking, and distribution of pharmaceutical Natrapharm AD Drugstel products to pharmaceutical outlets GX International Euro-med REPUBLIC ACT No. 10918 - "Philippine Pharmacy Act” c. Toll Manufacturers Lloyd laboratories Sydenham Lab Hizon Laboratories Swiss Pharma Interphil Laboratories Interchemix Pharma La Croesus Pharma Ashford Laboratories EL Pharma Sample of Organizational Chart Administrative Order no. 2020-0017 Pharma Companies Industrial Pharmacy Industrial pharmacists are mainly involved in the research, design, development and testing of new medicines and treatments, ensuring their safety and quality. Area of Industrial Pharmacy Pharmaceutical Manufacturers refer to establishments engaged in any or all operations Research and development involved in the production of pharmaceutical products Manufacture and quality assurance including the preparation, processing, compounding, Drug information formulating, filling, packaging, repackaging, altering, Patent applications and drug registration ornamenting, finishing and labeling, preparatory to their Clinical trials and post-marketing surveillance storage, sale, or distribution, except the compounding and Sales and marketing filling of prescriptions in pharmaceutical outlets Management REPUBLIC ACT No. 10918 - "Philippine Pharmacy Act" Lesson 2: Pharmaceutical Product Lifecycle Management a. Multinational Companies About Product Life Cycle Management Is the process of managing the entire lifecycle of a product including GlaxoSmithkline Philippines s Boehringer Ingelheim its research, design, and manufacture, service, and disposal. Pfizer Roche Wyeth Drive for Lifecycle Management Bristol Myers Squibb Abbott Laboratories Bayer Decline in research and development productivity Novartis Schering Plough Escalation in average development costs Astrazeneca MSD Narrowing of return investment Sanofi-Aventis Servier Philippines Competition is soaring high Johnson & Johnson Merck Inc Competition from generics Dispersing markets Reference: Sir Ains’ PPT 1 Lifecycle: d. PRODUCT DISCONTINUATION All phases in the life of a product from the initial development Retention of documentation through marketing until the product's discontinuation (ICH - Q8) Sample retention Continued product assessment & reporting Phases of PLM Benefits of PLM Revenue acceleration Unit profit enhancement Lower costs and improved productivity Improved innovation and quality Key Considerations for Successful PLM Early start Strategic planning Establish clear leadership Knowledge and skills to support the process Preparation for the changing rules of government organizations Focus on profitability throughout the lifecycle Product Lifecycle Monitoring and gauging of the success of the process implemented. a. Early start approach should be proactive Humira (Adalimumab) ○ 2002 - rheumatoid arthritis ○ 2005 - psoriatic arthritis ○ 2006 - Crohn's disease ○ 2012 - Ulcerative Colitis Pharmaceutical Quality System (ICH 010) Zyprexa (Olanzapine) a. PHARMACEUTICAL DEVELOPMENT ○ 1996 - psychotic disorder Drug substance development ○ 2003 - depressive disorder Formulation development (bipolar disorder) Manufacture of investigational drugs ○ 2004 - long term tx of bipolar Delivery System development disorder Manufacture process development & scale-up Analytical method development b. Strategic planning establish PLM teams b. TECHNOLOGY TRANSFER ○ Abbott Laboratories New product transfers during development through central data repository for access of all information on manufacturing molecule development and clinical testing Transfers within or between manufacturing sites for marketed products c. COMMERCIAL MANUFACTURING Acquisition and control of materials Provision of facilities, utilities and equipment Production Quality Control and Assurance Release Storage Distribution Reference: Sir Ains’ PPT 2 c. Preparation for the changing rules of government organizations Lesson 3: Pharmaceutical Manufacturing Facilities and Its Change in labeling requirements Functions Typical Pharmaceutical Plant Department (Organizational structure) The manufacturer must have an organization chart in which the relationships between the heads of Production, Quality Control and where applicable Head of Quality Assurance or Quality Unit and the position of the Authorized Person(s) are clearly shown in the managerial hierarchy. ↓ Computer Aided Drug Design A. FIRST DEPARTMENT: PRODUCTION CONTROL a. PRODUCTION CONTROL 1ST SECTION: PURCHASING In-charge of purchasing / buying requisitioned materials (both raw materials and packaging materials) from local or imported suppliers. b. PRODUCTION CONTROL 2ND SECTION: INVENTORY CONTROL 1. Watches and closely monitors the flow of materials in the warehouse. 2. Maintain and update the stock records of all materials issued in the Production Area. Reference: Sir Ains’ PPT 3 3. Periodically checks the remaining balance / quantity of ○ Materials which have undergone the initial QC tests materials. and passed. It conforms USP standards and specifications. ○ Ready to be used in the Production Area. Rejected Area ○ Contain Rejected materials. ○ Bears RED Sticker ○ Materials which have undergone the initial QC tests and failed to conform to USP specifications and c. PRODUCTION CONTROL 3rd SECTION: PLANNING AND SCHEDULING standards. 1. Coordinates with the Marketing Department on what ○ Absolutely not used in the Production Area. products are required for supply. 2. Prepares the schedule of production, and the MO / FO documents B. SECOND DEPARTMENT: WAREHOUSE Storage and Distribution Area for various classes of materials and products. The most important records in this department are the: ○ Inventory Cards - quantity received, issued and balance stock ○ Distribution Records for Finished Products b. WAREHOUSE 2ND SECTION: IN-PROCESS PRODUCTS (INTERMEDIATE PRODUCTS) Before any processing operation is started, steps should be taken to ensure that the work area and equipment are clean and free from any starting materials, products, product residues or documents not required for the current operation. Intermediate and bulk products should be kept under appropriate conditions. Critical processes should be validated a. WAREHOUSE 1ST SECTION: STARTING MATERIALS Any necessary in-process controls and environmental Starting materials in the storage area should be controls should be carried out and recorded. appropriately labelled Any significant deviation from the expected yield should be ○ Labels should bear at least the following information: recorded and investigated. The designated name of the product and the internal code reference where applicable; c. WAREHOUSE 3RD SECTION: FINISHED PRODUCTS A batch number given at receipt; Finished products should be held in quarantine until their Where appropriate, the status of the contents final release under conditions established by the (e.g. in quarantine, on test, released, rejected); manufacturer. Where appropriate, an expiry date or a date The evaluation of finished products and documentation which beyond which retesting is necessary. is necessary before release of product for sale are described Quarantined Area in Chapter 6 (Quality Control). ○ Contain quarantined materials After release, finished products should be stored as usable ○ Bears YELLOW Stickers stock under conditions established by the manufacturer. ○ Materials which are still subject to QC tests and should not yet be used in the Production Area. d. WAREHOUSE 4TH SECTION: RETURNED PRODUCTS Approved for Use Area Rejected materials and products ○ Contain Approved for Use Materials ○ Clearly marked as such and stored separately in ○ Bears GREEN Stickers restricted areas. Reference: Sir Ains’ PPT 4  ○ Either be returned to the suppliers or, where C. THIRD DEPARTMENT: ENGINEERING AND MAINTENANCE appropriate, reprocessed or destroyed. Takes charge of the repair, cleaning and maintaining the Reprocessing of rejected products condition of all machines, instruments, apparatus and ○ The quality of the final product is not affected machines used in all stages of processing products. ○ The specifications are met This include, water pipes, electrical lines, plumbing and ○ It is done in accordance with a defined and sewage, trash/refuse disposal, recycling, environmental authorized procedure after evaluation of the risks sanitation and housekeeping, carpentry works, involved. telecommunication systems. Products returned from the market: ○ Should be destroyed unless without doubt their D. FOURTH DEPARTMENT: MANUFACTURING / PRODUCTION quality is satisfactory; The complete set of activities to produce a drug that comprise ○ May be considered for re-sale, relabelling or recovery production and quality control from dispensing of materials to the with a subsequent batch only after they have been release for distribution of the finished product. critically assessed by the Quality Control Department in accordance with a written procedure. Where any doubt arises over the quality of the product: ○ Should not be considered suitable for re-issue or re- use ○ Basic chemical re-processing to recover active ingredients my abe possible. e. WAREHOUSE 5TH SECTION: DISPENSING Weighing of starting materials usually should be carried out in a separate weighing room designed for that use. Starting materials should only be dispensed by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers. Each dispensed material and its weight or volume should be independently checked and the check recorded. Materials dispensed for each batch should be kept together and conspicuously labelled as such. Reference: Sir Ains’ PPT 5