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Industry Based Education (INBED)

• INBED is Industry Based Education

Objective of INBED

• To understand the processes involved in pharmaceutical manufacturing.
• To learn about materials, equipment, and techniques used in operations.
• To describe standard operating procedures and good manufacturing practices.
• To understand the regulatory process for product approval and registration.
• To learn about sales and marketing strategies.

During Attachment

• Understanding the importance of documentation as a means of control.
• Understanding mechanism for packaging and label control to prevent mix-ups and cross-contamination.
• Certain technical language and their definitions such as Batch/Lot, Batch Number, Active Ingredient, Inactive Ingredient, Quality Assurance, and Quality Control Unit.
• Focus on the basic principles underlying the design and construction of buildings and facilities of a pharmaceutical plant (lighting, plumbing, sewage/refuse, ventilation, washing and toilet facilities sanitation).

Pharmaceutical Industry

• The pharmaceutical industry consists of companies researching, developing, producing, marketing, and selling drug products.
• The pharmaceutical industry in Ghana includes companies primarily engaged in manufacturing, fabricating, and processing materials into finished products.

Pharmaceutical Manufacturer

• Pharmaceutical Manufacture includes all operations of purchase of materials and products, production, quality control (QC), release, storage, and distribution of pharmaceutical products and related controls.
• A manufacturer is a company that carries out processes such as production, packaging, repackaging, labeling, and re labeling of pharmaceuticals
• As a manufacturing business, it should be registered with the FDA.
• Must have market authorization to be a manufacturer of a product.

Marketing Authorization

• Marketing authorization is a legal document issued by the regulatory authority (FDA) establishing the detailed composition and formulation of the product.
• Details of packaging, labeling, and shelf-life are also included.

Authorized Person

• A person recognized by the national regulatory authority and has responsibility for ensuring each batch of finished product is manufactured, tested, and approved in compliance with the laws/regulations in force in that country.

Pharmaceutical Quality System

• Manufacturers must assume responsibility for the quality of pharmaceutical products.
• Pharmaceutical products must be fit for use, comply with marketing authorization requirements, and ensure patients aren't at risk from safety, quality, or efficacy issues.

PQS (Pharmaceutical Quality System)

• Achieving quality objectives requires participation/commitment from staff in various departments and management levels, including the company's suppliers and distributors.
• Achieving quality relies on a comprehensive and correctly implemented pharmaceutical quality system (PQS).
• The PQS incorporates Good Manufacturing Practices (GMP) and Quality Risk Management (QRM).

Quality Unit

• An organizational unit which is independent of production that fulfills both quality assurance (QA) and quality control (QC) responsibilities.
• The Quality Unit can be in the form of separate QA and QC units, or a single individual or group.

Production

• Production encompasses all operations involved in the preparation of a pharmaceutical product, from receiving materials through processing, packaging, labeling, and completion of the finished product
• Components are the materials used for production, and it means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the drug product itself (alcohol, water).

Components

• Active Pharmaceutical Ingredient (API): Any component intended to provide pharmacological activity or direct effect in diagnosis, cure, relief, treatment, or prevention of disease
• Excipients: Any component other than an active ingredient, also known as inactive ingredients, that play different roles in formulation and are selected carefully

Material Terminology

• Starting materials are any substance of a defined quality used in the production of a pharmaceutical product.
• Intermediate product refers to -partly processed product that must undergo further manufacturing steps before it becomes a bulk product
• Bulk product constitutes any product that has completed all processing up to, but not including, final packaging.
• Packaging material includes any material, including printed material, employed in the packaging of a pharmaceutical.
• A finished product is a finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.

Manufacturing

• The conversion of materials, including
  • The conversion of Active pharmaceutical ingredients API
  • Excipients (auxiliary materials)
  • Packaging materials
• The conversions result in Finished goods
• Waste products remain

Packaging

• Packaging includes all operations, including filling and labelling, that a bulk product undergoes to become a finished product.
• Sterile product filling under aseptic conditions is separate to packaging.
• Packaging material is any material employed in the packaging of a pharmaceutical, including printed material.
• Packaging materials get classified as primary or secondary based on whether they are intended for direct contact with the product.

Master Formula

• A Master Formula is a document or set of documents specifying the starting materials and their quantities, the packaging materials, and the procedures/precautions required to produce a specified quantity of a finished product, including in-process controls.

In-Process Control

• In process control refers to checks performed during production to monitor and adjust the process, ensuring the product meets specifications.
• Environment or equipment control can also be considered part of in-process control.

Master Record

• A Master Record is a document or set of documents that serve as a basis for batch documentation (blank batch record).

Batch Records

• Batch records includes all documents linked with the manufacture of a bulk or finished product batch.
• Batch records also provide a detailed history and documentation related to the characteristics of each product batch.

Strength

• Strength refers to the concentration of the drug substance
  • For example weight of active in/weight of tablet 500mg paracetamol in 560mg tablet
  • The weight of active in /standard volume
  • 125mg paracetamol in 5ml of cetapol syrup
  • or a unit dose/volume basis 30ml glycerin
• Strength refers to the potency that is the therapeutic activity of the drug
  • Therapeutic data also requires clinical data.
  • For example Insulin

Batch

• Batch is a specific quantity of a drug or other material which has uniform character and quality within specified limits
• A Batch undergoes a single manufacturing order during the same cycle of manufacture.
• It may be necessary to divide batches into multiple sub-batches
• All sub-batches are combined to form a final homogeneous batch

Batch Number

• Batch number, control number, and lot number, can be a any unique combination of numbers, symbols, or letters.
• A batch number provides history of the manufacture, packing, processing, holding and distribution of drug product materials.

Yield

• Reconciliation refers to a comparison between theoretical and actual quantities

• Theoretical yield is the quantity that would be produced at the appropriate phase

  • Measurement is dependent on the amounts of components
  • Actual yield refers to the quantity that is produced after processing

• Percentage of a theoretical yield is the calculation of ratios between actual and theoretical yields during processing

Other Materials

• Types if other materials;
  • Rejected and Recovered materials
  • Recalled Products
  • Returned Goods
  • Reagents and culture media
  • Reference Standards
  • Waste Materials
  • Miscellaneous Materials