Preformulation Means Characterization - - BioPharm International

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Preformulation Means Characterization


BioPharm International


Documentation comprises a complex and interconnected network of records and forms — merely introducing the subject in BioPharm International required an 11-part column series (see References). GMP articles and columns continue to explain and define critical documentation elements.

Part numbers are assigned as identification codes for tracking purchases, material flow, and inventory. They are especially important for "critical" items, those that form part of a product or come into contact with it (vials, stoppers, and seals, for example). Specifications describe in detail every numbered item (purchasing information, chemical formulas, handling precautions, storage conditions, expiration dates, testing requirements, and so on). Incoming materials are monitored through receiving codes and assigned lot numbers — as are solutions prepared in-house, cell-lines, processing events, and production batches. Standard operating procedures (SOPs) provide step-by-step instruction for technicians in QC, production, maintenance, and material handling. A Master Production Batch Record (MPBR) details the production process step by step, ensuring that all vials are exposed to the same processing conditions as the product moves through formulating, sterilizing, filling, sealing, inspecting, and labeling. The MPBR begins with cell-culture inoculation and proceeds through harvest and even initial purification steps.

Meanwhile, equipment installation qualification evaluates the assembly and installation of critical processing equipment — including its own set of SOPs and materials specifications. Log books and work orders track equipment monitoring, repairing, cleaning, and preventive maintenance.

And what of the big picture? As documention is developed throughout a facility, protocols are written as "umbrella documents" to tie individual SOPs together and to direct the work. Protocols even describe where in the company to find specific files and documents. They tell who directs which activities, who approves what, and who is allowed to sign off on materials and products. Performance qualification sections, for example, describe preliminary operations and validation acceptance criteria. Master method validation protocols help scientists develop, monitor, evaluate, and adapt analytical protocols. And process validation protocols help them determine whether and how to validate various critical aseptic manufacturing processes.

Documentation (which includes much more than is mentioned here) supports the work in development laboratories and throughout scale-up, production, manufacturing, and even postmarket surveillance. It helps ensure product consistency from batch to batch — and helps instill physician and patient confidence in the safety of the final formulation.


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