Document builder · Pharmaceutical
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Quality Assurance
Preparation, Approval and Control of Standard Operating Procedures
How procedures are written, numbered, reviewed, approved, issued, revised and withdrawn, so that only the current approved version is ever in use.
Handling of Deviations
Reporting, classifying, investigating and closing any departure from an approved procedure, specification or expected result.
Change Control
Proposing, assessing, approving, implementing and closing any change that could affect product quality, the validated state or a regulatory commitment.
Corrective and Preventive Action (CAPA)
Raising, planning, completing and verifying the effectiveness of corrective and preventive actions from deviations, complaints, audits and trends.
Handling of Product Complaints
Receiving, recording, classifying, investigating and answering complaints about product quality, and deciding whether a recall is needed.
Product Recall
Deciding on, carrying out and closing a recall, including notification, retrieval, reconciliation and the yearly mock recall.
GMP Training of Personnel
Induction, job-specific and refresher training, how it is assessed and recorded, and the rule that no one works unsupervised before being trained.
Self-Inspection (Internal Audit)
Planning and carrying out internal GMP audits, grading the findings and following corrective actions through to closure.
Qualification and Approval of Suppliers
Assessing, approving, monitoring and removing suppliers of starting and packaging materials, by risk.
Batch Record Review and Batch Release
Checking the manufacturing, packaging and testing records of a batch before it is certified and released for sale.
Quality Control
Investigation of Out-of-Specification Results
What to do when a test result is outside its limit: the laboratory check first, then the full investigation, retesting rules and the batch decision.
Daily Verification and Use of Weighing Balances
Checking a balance with certified weights before use each day, the acceptance limits, and what to do when a check fails.
Disintegration Test for Capsules
Testing six capsules in the disintegration apparatus at 37 ± 2°C, with the two-stage acceptance criteria, cleaning and records.
Sampling of Starting and Packaging Materials
How many containers to sample, where and with what, how to avoid contaminating the material, and how to label the sample and the sampled container.
Production
Line Clearance
Clearing and checking a room, line or machine before each batch, so nothing from the previous product, batch or pack can mix with the next.
Cleaning of Production Equipment
Cleaning product-contact equipment between batches and products, with defined hold times and a documented check that it is visually clean.
Gowning and Personal Hygiene for Production Areas
Health, hygiene, hand washing and the gowning sequence for entering and leaving production areas.
Dispensing of Raw Materials
Weighing and issuing raw materials for a batch: checks before weighing, one material at a time, independent verification and labelling.
Cleaning and Sanitisation of Production Areas
Daily, weekly and periodic cleaning of rooms: the order to work in, the agents to use, rotating disinfectants and recording the cleaning.
Warehouse
Receipt, Quarantine and Storage of Materials
Checking a delivery, labelling it, holding it in quarantine until released, and storing it under the right conditions with first-expiry-first-out.
Pest Control
Preventing pests, the map and inspection of bait stations and traps, what is not allowed inside production, and acting on any sighting.
Engineering
Calibration of Measuring Instruments
Keeping a register of instruments, calibrating them on schedule against traceable standards, labelling them and acting when one is found out of tolerance.
Preventive Maintenance of Equipment
Planned maintenance of production equipment and utilities, breakdown repairs, and handing equipment back clean and fit for use.
More documents are on the way
The builder starts with pharmaceutical Standard Operating Procedures. More procedures, then forms, records and policies, and after that other industries, will be added the same way.
Every document is a starting point written to GMP principles. Before use it must be checked against your own site, products and regulatory requirements, and approved through your own quality system.