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Industrial Pharmacy/2013
Industrial Pharmacy/2013
What are the basic types of documents? Basically there are three types of Documents 1. Commitment Documents: Relationship between industry and the regulatory authorities, employees, other manufacturers, suppliers, vendors, distributors and different unions. Commitment document presents the organizational goals. It has policies and legal documents of the organization (A document to establish the organization interpretation and attitude towards the regulatory body ). It includes: o Employment contract o Manufacturing licenses o New Drug Applications (NDAs), o Drug Master Files (DMFs). o Product registration
Industrial Pharmacy/2013
Industrial Pharmacy/2013
What are the major parts of a standard document for GDP? Along with the main body of a document, addressed/approved by whom and addressed to whom, a standard document must also include: o Document number/continuity number (in case of updating) o Document type o Document creator o Document recorder o Documentation time and date o Document evaluator o Document reviewer o Document verifier o Date and time of re-evaluation Usually these parts are placed at header/footer position of a document. A good document also contains little space for important notes and remarks.
How and by whom documentation is done? Usually the documentation is done by the management of the respective department under the supervision of quality assurance department. Quality assurance department provide the basic lines/chart/form about the documentation and respective department create relevant document by its proper filling or recording the information required.
Industrial Pharmacy/2013
Industrial Pharmacy/2013
Industrial Pharmacy/2013
Equipment assembly and validation Analytical apparatus and calibration Maintenance, cleaning, and sanitization Personnel matters including qualification, training, and hygiene Environmental monitoring Pest control and assigning responsibility for cleaning and sanitation Written release and rejection procedures Complaints, Recalls, Returns and Sampling For testing materials and products at different stages of manufacture describing the methods and equipment to be used.
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For describing the details of the batch (lot) numbering system For the internal labelling, quarantine and storage of starting materials, packaging materials and other materials
For the receipt of each delivery of starting material and printed packaging material Some suggested readings
Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use (US FDA, Chapter 4. Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS WHO. Good Manufacturing Practices for Pharmaceutical Products: Main Principles. EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. Volume 4.
Industrial Pharmacy/2013