Industry Based Pharmaceutical Education PDF

INDUSTRY BASED EDUCATION INBED OBJECTIVE Of INBED  Understand processes involved in the Pharmaceutical manufacturing  Materials ,Equipment, Techniques used in operations  Describe the standard operating procedures ,Good Manufacturing Practises  Regulatory process fo...

INDUSTRY BASED EDUCATION INBED OBJECTIVE Of INBED  Understand processes involved in the Pharmaceutical manufacturing  Materials ,Equipment, Techniques used in operations  Describe the standard operating procedures ,Good Manufacturing Practises  Regulatory process for the approval and registration of products  Sales and Marketing strategies During attachment Certain technical language and their definition eg Batch/ Lot, Batch Number, Active Ingredient, Inactive Ingredient, Quality Assurance, Quality Control Unit, The basic principles underlying the design and construction of buildings and facilities of a pharmaceutical plant i.e lighting, plumbing, sewage/refuse, Ventilation(air filtration heating cooling) washing and toilet facilities sanitation etc  Personnel requirement and training needs of staff working in these environment.  Understand the importance of documentation as a means of control.  In process control appropriate for the type of manufacture to assure the batch uniformity and integrity of products.  Understand the reason and mechanism for packaging and label control so as to prevent mix ups and cross contamination. INDUSTRY  The Pharmaceutical Industry is made up of companies that research, develop, produce, market and sell drug products.  In Ghana pharmaceutical industry includes companies that are primarily engaged in manufacturing, fabricating and processing materials into finished products. PHARMACEUTICAL MANUFACTURER Manufacture. All operations of purchase of materials and products, production, quality control (QC), release, storage and distribution of pharmaceutical products, and the related controls.  A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals is a manufacturer. As a manufacturer the business should be registered with the FDA as such Before you can be a manufacturer of a product you should have market authorisation Marketing authorization (product licence, registration certificate). A legal document issued by the competent medicines regulatory authority( FDA) that establishes the detailed composition and formulation of the product and the pharmacopoeia or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life. Authorised person The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.  Pharmaceutical Quality system The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are  fit for their intended use,  comply with the requirements of the marketing authorization and  do not place patients at risk due to inadequate safety, quality or efficacy. PQS  The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers and the distributors.  To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented pharmaceutical quality system (PQS) incorporating Good Manufacturing Practises (GMP) and Quality Risk Management(QRM ) Quality Unit An organizational unit independent of production which fulfils both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group , depending upon the size and structure of the organization. Production Production- All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product. The materials used for production are sometimes called components Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product eg alcohol, water. COMPONENTS ACTIVE PHARMACEUTICAL INGREDIENT (API). Active ingredient means any component that is intended to give pharmacological activity or other direct effect in the diagnosis, cure, relief, treatment or prevention of disease.  EXCIPIENTS  Inactive ingredient means any component other than an active also known as excipients  Play different roles in formulation and are selected carefully  Material Terminology Starting materials- Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials. intermediate product. -Partly processed product that must undergo further manufacturing steps before it becomes a bulk product. Bulk product. Any product that has completed all processing stages up to, but not including, final packaging. Packaging material. Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. finished product. A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling. Manufacturing  Conversion of Materials ie combination  Active pharmaceutical ingredients API  Excipients (auxiliary materials)  Packaging materials  These give Finished goods  Waste products Packaging  All operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized, would not normally be regarded as part of packaging. packaging material. Any material, including printed material, employed in the packaging of a pharmaceutical.  Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. MASTER FORMULA  A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. In-process control.  Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control. Master record. A document or set of documents that serve as a basis for the batch documentation (blank batch record). Batch records. All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product. Strength  Strength means i. the concentration of the drug substance for example weight of active in/weight of tablet 500mg paracetamol in 560mg tablet weight of active in /standard volume 125mg paracetamol in 5ml of cetapol syrup or unit dose/volume basis 30ml glycerin Strength  ii the potency that is the therapeutic activity of the drug that is adequately developed and controlled based on clinical data. (expressed for example in terms of units by reference to a standard). Eg Insulin Batch  Batch means a specific quantity of a drug or other materials that is intended to have uniform character and quality within specified limits and is produced according to a single manufacturing order during the same cycle of manufacture. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch  In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval. BATCH NUMBER  Lot number, control number or batch number means any distinctive combination of letters, numbers or symbol or any combination of them, from which the complete history of the manufacture, processing, packing, holding and distribution of a batch or lot of drug product or other material can be determined. Yield Reconciliation. A comparison between the theoretical quantity and the actual quantity. Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.  Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.  Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. Other Materials  Rejected and recovered materials  Recalled products  Returned goods  Reagents and culture media  Reference standards  Waste materials  Miscellaneous materials-Materials for cleaning, lubrication, technical items and pest control QUESTIONS???