Monday, June 22, 2009

Quality Management and documentation

Quality Management:
1-1 There should be a documented quality policy describing the overall intentions and policies of the establishment regarding quality, as formally expressed and authorized by upper management.
1-2 Quality management should include:
 Appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and
 Systematic actions necessary to ensure adequate confidence that a product (or service) and documentation will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”.
1-3 Where electronic commerce (e-commerce) is used, defined procedures and adequate systems should be in place to ensure traceability and confidence in the quality of Materials and pharmaceutical products.
2- Documentation: instructions, written SOPs and records: 2-1 Good documentation is essential part of Good Distribution and storage practice. Documenting working actions main objectives are to avoid errors or misjudgments, to be sure that the same (consistent) methods are used at each time, to make sure that the used instruments are working properly according to set standards and to ensure recording of all steps (actions) followed on receiving and storing of the materials and products. 2-2 written standardized work procedures (SOP), instructions and records should be:
 Available for review
 To clearly explain work procedures.
 To include and document all activities and procedures followed in the storage premises.
 To clearly identify the distribution channels for materials and products.
2-3 among others, written standardized operation procedures (SOP) should be in place for the following:
 Dealing with expired stock
 Procedures to be followed in case of RECALL of any products.
 Authorized procurement and release procedures should be in place, to ensure that appropriate pharmaceutical products are sourced from approved, legitimate and licensed suppliers and distributed by approved legitimate entities.

2-4 there should be written procedures and records to ensure traceability of the products distributed from the point of production by the manufacturer covering all entities in the supply chain as they should be traceable as applicable until it reaches the final user. All information and details in this regard should be recorded and documented in a meaningful manner for concerned official authorities (Customs, Drug Control Dept…) as well as for other parties within distribution channels and final user. 2-5 A data Sheet of permanent information, written or electronic, should exist for each stored material or product indicating:
 Brand name, International Non-Proprietary Name (INN) name/s
 recommended storage conditions,
 any precautions to be observed
 retest dates
 Pharmacopoeial requirements
 Art work of labels and containers.
 Safety and first aid instructions.
2-6 Records should be kept for each delivery and must be retained for a period equal to the shelf-life of the incoming materials and products, where applicable, plus 1 year). They should include the following:
 description of the received goods ( Pharmaceutical Dosage form, size and presentation of pack unit, number of units per pack, and any other important detail like supplementary accessories and so)
 quality
 quantity
 supplier
 supplier’s batch number
 the date of receipt
 assigned batch number
 Expiry date.
2-7 Comprehensive records should be maintained showing all receipts and relevant invoices, including purchase orders and issues of materials and pharmaceutical products according to a specified system, e.g. by batch number, stock cards…

3- Labeling
1- Labels applied to containers should be clear, unambiguous, permanently fixed to the container and be indelible. The labeling should be written in a language which is understood by persons involved in the distribution chain as well for relevant official authorities. 2- All containers and packaged stored material or products should be labeled clearly. 3- Labels on secondary packaging should include at least the following:
- Material or product name (Brand name if applicable and the INN name in addition to pharmacopeias if applicable)
- Quantity (weight, size, unit number)
- Batch number
- Expiry date or retest date for active ingredients.
- Receiving date
- Production date
- Quality Control section approval and release date with signature of person in charge.
- Storage conditions (clear and specific)
- Transportation conditions and precautions.
- Handling precautions
- Manufacturer name with its trade mark.
- Supplier’s name (in case it is a wholesaler or so) with contact details.
- When used, only internationally and/or nationally accepted abbreviations, names or codes should be used in the labeling of containers. Use of abbreviations or symbols should be avoided.
4- Self inspection 1- The system of quality assurance should include self-inspections. These should be conducted in order to monitor the implementation and compliance with the principles of GD &SP mentioned in this issue and to trigger necessary corrective and preventive measures. 2- Self-inspections should be conducted in an independent and detailed way by a designated, competent person. 3- All self-inspections should be recorded. Reports should contain all observations made during the inspection and, where applicable, proposals for corrective measures. Follow- up corrective actions taken should be documented and rec

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