Pharmaceutical Ingredients and Active Constituents

Pharmaceutical Terminology

• Active ingredients are herbal materials or preparations with known therapeutic activities, standardized to contain a defined amount of constituent(s).
• Active pharmaceutical ingredient (API) is a substance or mixture of substances intended to furnish pharmacological activity or other direct effects in diagnosis, cure, treatment, or prevention of disease.

Cleanroom and Contamination Control

• An airlock is an enclosed space with two or more doors, interposed between two or more rooms, to control airflow between those rooms.
• Clean Area is an area with defined environmental control of particulate and microbial contamination, constructed to reduce the introduction, generation, and retention of contaminants.

Manufacturing and Processing

• Blending is the process of combining materials or different batches to produce a homogeneous intermediate or finished product.
• Batch is a defined quantity of starting material, packaging material, or product processed in a single process or series of processes, expected to be homogeneous.
• Batch number (or lot number) is a distinctive combination of numbers and/or letters that uniquely identifies a batch on labels, batch records, and corresponding certificates of analysis.
• Batch Records are documents associated with the manufacture of a batch of bulk product or finished product, providing a history of each batch and circumstances pertinent to the quality of the final product.

Product Quality and Control

• Calibration is the set of operations that establish the relationship between values indicated by an instrument or system and corresponding known values of a reference standard.
• Critical operation is an operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.
• Cross-contamination is the contamination of a starting material, intermediate product, or finished product with another starting material or product during production.

Product and Packaging

• Bulk product is any product that has completed all processing stages up to, but not including, final packaging.
• Finished product is a finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labeling.
• Consignment (Delivery) is the quantity of a pharmaceutical made by one manufacturer and supplied at one time in response to a particular request or order.

Regulation and Compliance

• Marketing authorization (product license, registration certificate) is a legal document issued by the competent drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopeia or other recognized specifications of its ingredients and of the final product itself.
• Master formula is 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.
• Quarantine is the status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing.