electronic Quality Management System (eQMS)

21 CFR Part 211.100

There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity  they purport or are represented to possess.  Written production and process control procedures shall be followed in the  execution of the various production and process control functions and shall be  documented at the time of performance.

EduraLex DIRECTIVE 2003/94/EC Article 10

The different production operations shall be carried out in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice.

21 CFR Part 211.25

Training shall be in the particular operations that the employee performs and in  current good manufacturing practice (including the current good manufacturing  practice regulations in this chapter and written procedures required by these  regulations) as they relate to the employee's functions. Training in current  good manufacturing practice shall be conducted by qualified individuals on a  continuing basis and with sufficient frequency.

211.34  Consultants advising on the manufacture, processing, packing, or holding of drug  products shall have sufficient education, training, and experience, or any  combination thereof, to advise on the subject for which they are retained.

DIRECTIVE 2003/94/EC Article 10 

At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the pharmaceutical quality assurance objective.

21 CFR Part 211.100

Any deviation from the written procedures shall be recorded and justified.

DIRECTIVE 2003/94/EC Article 10

All process deviations and product defects shall be documented and thoroughly investigated.

21 CFR Part 211.100

.....any changes, shall be drafted, reviewed, and approved by the appropriate  organizational units and reviewed and approved by the quality control unit.

DIRECTIVE 2003/94/EC Article 9

That set of documents shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced.

21 CFR Part 211.192

Any unexplained discrepancy (including a percentage of theoretical yield  exceeding the maximum or minimum percentages established in master production  and control records) or the failure of a batch or any of its components to meet  any of its specifications shall be thoroughly investigated, whether or not the  batch has already been distributed. The investigation shall extend to other  batches of the same drug product and other drug products that may have been  associated with the specific failure or discrepancy. A written record of the  investigation shall be made and shall include the conclusions and follow-up.

DIRECTIVE 2003/94/EC Article 13 

Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination.

1 CFR Part 211.192

Written procedures describing the handling of all written and oral complaints  regarding a drug product shall be established and followed. Such procedures  shall include provisions for review by the quality control unit, of any  complaint involving the possible failure of a drug product to meet any of its  specifications and, for such drug products, a determination as to the need for  an investigation in accordance with 211.192.

DIRECTIVE 2003/94/EC Article 13 

In the case of medicinal products, the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated  by the manufacturer.

21 CFR Part 820.100 (Medical Device)

Each manufacturer shall establish and maintain procedures for implementing  corrective and preventive action.

DIRECTIVE 2003/94/EC Article 14 Self Inspection

The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures.