Unit 1: Introduction to Product Life Cycle Management

primary manufacturing

Manufacturing of API and excipients

Secondary manufacturing

Manufacturing of finished dosage form

Tertiary manufacturing

packing, labeling, repacking of finished bulk products

Drugs

Intended for having as their main use the diagnosis, cure, mitigatio, treatment, or prevention of disease in man and other animals

Drugs

• Recognized by monograph in the compendia

• (Other than food) Used to affect the structure or any functions of the body of man and other animals

Pharmaceutical preparations

Are means of administering drugs as formulate preparations

Dosage forms

Are combination of a drug entity and drug additives

Drug products

Are finished dosage form that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients

batch

A specific quantity of a drug or other material 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

Lot

A batch or specific indentified portion of a batch having uniform character and quality within specified limits and a instinctive identifying lot number

Batch/lot/control numbera

Any distinctive combination of letters, numbers or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of drug product or other material can be determined

Active ingredient

• Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment of prevention of disease or to affect the structure or function of the body of man or other animals

• Includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect

Inactive ingredient

• Any component other than active ingredient

• Provides the drug or active therapeutic agent in a form suitable for administration to a patient with assurance that the optimum therapeutic effects will result

• Emulsify, stabilise, suspend, preserve, dilute, solubilize, flavor, etc.

• Harmless in amounts used

• Minimum quantity required to provide their intended effect

• Does not impair the bioavailability or therapeutic efficacy of the dosage form

• Does not interfere with the assays and tests prescribed for determining their compliance

Requirements for inactive ingredients

Food/dietary supplement

• Means processes food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements

• Not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines

• No approved therapeutic claims

RFID

• Wireless use of electromagnetic fields to transfer data, for the purposes of automatically identifying and tracking tags attached to objects

• Tags contain electronically stored information

• RM, pharmaceuticals tracked in warehouses

• Stock number, lot or batch number, production date

Component

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such product

In-process material

Any material fabricates, compounded, blended or derived by chemical reaction that is produced for, and used in, the preparation of the drug product

Bulk product

Given quantity of any substance or product that can further be subdivided during the process of manufacture

Master record

• Master formula

• Records containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labelling of a finished product

Drug trader

Registered owner of the drug product but contracts toll manufacturers

Toll manufacturing

agreement whereby a competent company processes a raw materials or semi-finished goods or package products for another company

Drug manufacturer

Is any establishment engaged in operations involved in the production of drugs

Drug importer

Imports raw materials or finished products from other countries for distribution to drug outlets

Drug exporter

Exports raw materials or finished products to be distributed to the other countries

Drug wholesaler

Acquire raw materials or finished products from local establishment distribute on a wholesale basis

• Ethical manufacturer

• Proprietary/generic manufacturer

• Biologicals manufacturer

• Veterinary products manufacturer

• Medicinal chemical manufacturers

• Toll/contract manufacturers

different drug manufacturer

• Administration

• Manufacturing

• Finance

• Quality assurance

• Research and development

• Distribution

• Medical affairs

• Marketing

• Regulatory affairs

• Sales

• Procurement and logistics

Departments in a pharmaceutical establishments

Warehouse

• RM and PM section

  • Quarantined materials

  • Approve for use materials

  • Rejected materials

• In-process

• Finished products/goods

• Returned goods

• Dispensing

Research department

• Develops products to be marketed by the company

• Library, animal house, pilot plant

Production/manufacturing department

• Receives materials and supplies

• Oversees warehousing and storage and shipping of the final product to the customers

• Manufactures and packages products

• Exercises production, personnel, labelling, and packaging control

Engineering Department

• Locates and installs equipment

• Maintains and repairs equipment

• Maintains plant services

• Ensures plant and employee safety

Quality control department

• Heart and soul of drug manufacturer

• Ensures that the materials, products and processes in the manufacture of the products are in accordance with the predetermined quality characteristics

• Sampling, testing, assaying of drugs

Production control division

• Purchasing dept, inventory control, planning and scheduling

Marketing department

• Sales of products

• Creates the demand for the products

• Promotes the maximum volume of sales of products

Medical department

• Conducts physical and medical examination of new employees

• Oversees the medical treatment of employees

• Performs clinical studies

• Prepares literature and package inserts

• Publishes house organ

• Handles scholarships

Administration

Determines the overall direction of the company and takes care of the day to day operations of the company

• Executive offices

• Human resources department

• Organizational development

• Legal department

Under the administration, there are different department and offices such as:

Regulatory department

• liaises with the regulatory bodies on the registration of the company and its product

distribution

• Makes products physically available to the trade (customers)