What is considered pharmaceutical manufacturing?
Pharmaceutical manufacturing includes the regulated activities used to convert APIs, excipients, biological materials, or intermediate products into finished medicines. Activities such as formulation, processing, filling, packaging, quality testing, and batch release can all form part of pharmaceutical manufacturing.
Answer
An activity is generally considered part of pharmaceutical manufacturing when it contributes directly to producing, processing, testing, packaging, or releasing a pharmaceutical product.
Examples of pharmaceutical manufacturing activities include:
• weighing and dispensing APIs and excipients
• formulation and compounding
• blending and granulation
• tablet compression and coating
• capsule filling
• preparation of oral liquids
• sterile solution preparation
• filtration and aseptic filling
• sterilization and lyophilization
• production of topical medicines
• pharmaceutical packaging and labeling
• in-process quality controls
• finished-product laboratory testing
• batch documentation and release
Pharmaceutical manufacturing can cover both active pharmaceutical ingredients and finished dosage forms, depending on the facility and regulatory framework.
It may also be divided into sterile and non-sterile manufacturing. Sterile manufacturing includes products such as many injections and ophthalmic medicines and requires particularly strict contamination controls. Non-sterile manufacturing can include tablets, capsules, syrups, suspensions, and many topical products.
Research, marketing, wholesale distribution, prescribing, and dispensing medicines are related pharmaceutical activities, but they are not normally manufacturing operations themselves.
Manufacturing is performed within a regulated quality system using qualified personnel, controlled facilities, documented procedures, and validated processes.
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