Areas of Operations for Quality Manual

The Quality System covers the following areas of operation:

1 Human Resources – to ensure that staff of appropriate educational level, experience and health are recruited, that their roles and responsibilities are clearly defined and that they are adequately trained, supervised, assessed and their competency recorded and monitored.

2 Facilities & Equipment – to ensure that facilities and utilities routinely operate within defined quality standards and that manufacturing equipment is at all times appropriately controlled.

3 Materials Management – to ensure that the suppliers of materials are routinely monitored for compliance with the requirements of a written supplier’s contract and those materials, including in-process and finished goods, are at all times appropriate labelled, segregated, stored, transported and their status recorded.

4 Documentation – to ensure that up-to-date information on the requirements of regulatory approvals, Governmental regulations, GMP/cGMP and Technical information on product and process design is at all times available to the site. That manufacturing and testing activity are carried out in compliance with written, approved SOPs & EOPs; that product manufacturing instructions are in compliance with these requirements and that appropriate batch manufacturing and testing records are generated and retained.

5 Process Controls – to ensure that production operations are carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice; that appropriate technical and / or organisational measures are taken to avoid cross contamination and mix-ups, and that any new manufacturing process or critical modification of a manufacturing process are validated, and critical phases of manufacturing processes are regularly reviewed and if necessary re-validated.

6 Laboratory Controls – to ensure that equipment in laboratory is appropriately qualified and calibrated; that laboratory reference materials and organisms are appropriately stored and controlled to assure their quality; that analytical and microbiology methods are validated and that laboratory records, including retained samples, are appropriately maintained.

7 Quality Assurance – to ensure that batches of product released to market have undergone a comprehensive review of manufacturing and testing data and are in compliance with the appropriate marketing licence requirements; that trends in manufacturing and testing data are monitored and considered in release decisions; that, should non-conforming products be found, including those which are subject to customer complaint, they are subject to investigation, and if necessary recall, if out in the marketplace, and that the performance of the company’s procedures and quality systems is subject to routine monitoring through a programme of self-inspection and product review.

8 Technology Transfer – to ensure that internal / external transfers of products / products for toll manufacturing, the processes / manufacturing or testing equipment that affect product quality take place in accordance with approved documented procedures and or received know-how.

9 Quality Risk Management (QRM)Quality risk management shall be applied to different stages of pharmaceutical product that include (i) development, (ii) manufacturing, (iii) distribution, (iv) inspection/auditing, (v) testing, (vi) regulatory submission and review of process throughout the lifecycle of products manufactured, (vii) qualification and validation of processes, facilities, process machines and laboratory instruments including computer system and PLC (programmable logic controllers) of machines, (viii) customer complaints, change control, calibration, quality investigation/deviation, maintenance, out of specification results, CAPA, supplier qualification, reworking/reprocessing, storage condition, training etc.

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