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Implementation of a pharmaceutical quality system
1. Manufacturers shall have in place a comprehensive pharmaceutical quality system designed to ensure the quality of the veterinary medicinal products. 2. Compliance with good manufacturing practice and the terms of the marketing authorisation shall be an essential part of the pharmaceutical quality system.
Requirements of the pharmaceutical quality system
1. The design of the pharmaceutical quality system shall be based on the following risk management principles: (a) the evaluation of the risks to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the user and the safety of the animals treated; (b) the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk. 2. While some aspects may be company-wide, the pharmaceutical quality system shall be developed and implemented at site level. 3. The size of the company and complexity of the relevant activities shall be taken into consideration in developing a pharmaceutical quality system or modifying an existing one. Senior management shall have the ultimate responsibility to ensure the effectiveness of the pharmaceutical quality system and, to that end, shall ensure that appropriate resources are allocated. 4. The pharmaceutical quality system shall be duly documented and the effectiveness thereof shall be monitored. 5. The pharmaceutical quality system shall ensure that: (a) there is an adequate number of personnel with the necessary qualifications and adequate training and there is clear allocation of responsibilities, including managerial responsibilities; (b) the premises and equipment are suitable for the intended use and they are appropriately maintained; (c) there is an adequate documentation system that ensures that appropriate specifications are laid down for materials used in the manufacture of the veterinary medicinal product, intermediate product, bulk product and finished product, that the production and quality control procedures are clearly defined, and that appropriate records are kept; (d) arrangements are put in place for the selection and monitoring of suppliers; (e) the manufacturing process is systematically reviewed to ensure that it is capable of consistently delivering a product of the required quality in compliance with the relevant specifications and the terms of the marketing authorisation; (f) appropriate controls on intermediate products and any other in-process controls and validations are carried out; (g) veterinary medicinal products are not sold or supplied before a qualified person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and in compliance with good manufacturing practice; (h) the results of product and process monitoring are taken into account in the context of batch release and in the investigation of deviations; (i) quality defects, deviations and other problems or unusual events that may have an impact on the quality of the veterinary medicinal product are identified as soon as possible, the causes investigated, and appropriate corrective and/or preventive measures are taken. The effectiveness of such measures shall be monitored and assessed; (j) arrangements are put in place for the prospective evaluation of planned changes and their approval prior to the implementation thereof taking into account applicable regulatory requirements, as well as for the evaluation of changes implemented (change control); (k) processes are implemented to ensure adequate management of outsourced activities; (l) knowledge related to the product and the manufacturing thereof is duly managed throughout the life-cycle of the veterinary medicinal product and in particular in the context of the transfer of activities and the implementation of changes to the manufacturing process or control procedures; (m) there is a process of self-inspection and/or quality audit which regularly appraises the effectiveness of the pharmaceutical quality system.
Product quality reviews
1. Product quality reviews shall be conducted and documented annually for each veterinary medicinal product, taking into account previous reviews, and shall include at least a review of the following elements: (a) materials used in the manufacturing process, especially those from new sources; (b) the supply chain traceability of active substances; (c) critical in-process controls and finished product results; (d) all batches that failed to meet established specification(s) and the investigation thereof; (e) significant deviations or non-conformances, the investigation thereof, and the effectiveness of resultant corrective and preventive actions taken; (f) changes carried out to the manufacturing process or analytical methods; (g) variations to the terms of the marketing authorisation affecting quality that have been submitted, granted or refused, as well as a review of post-marketing obligations affecting quality, including those relevant for veterinary medicinal products intended only for export; (h) the results of the stability monitoring programme and any adverse trends; (i) quality-related returns, complaints and recalls and the investigations performed at the time; (j) adequacy of any other previous product, process or equipment corrective actions; (k) the qualification status of relevant equipment and utilities, such as HVAC, water or compressed gases; (l) any contractual arrangements for outsourced activities to ensure that they are up to date. 2. Procedures shall be set for the conduct and evaluation of the product quality reviews and the effectiveness thereof shall be verified during the self-inspections referred to in Article 7. Product quality reviews may be grouped by product type (e.g. solid dosage forms, liquid dosage forms, sterile products), where scientifically justified. 3. The results of the product quality review shall be evaluated and it shall be assessed whether corrective and/or preventive actions or any revalidation is required. Where appropriate, opportunities for quality improvements shall be considered.
Self-inspection
1. Self-inspections shall be conducted to monitor the implementation of the arrangements regarding personnel, premises, equipment, documentation, production, quality control, batch release and arrangements to deal with quality-related complaints and recalls with the aim of verifying the suitability thereof to ensure that the veterinary medicinal products meet the required quality standards, and comply with the terms of the marketing authorisation and with good manufacturing practice. 2. Self-inspections shall be conducted at pre-defined intervals by individuals not involved in the audited activities. 3. Self-inspections shall be recorded. Reports shall include the observations made and, where applicable, proposals for corrective measures. The actions subsequently taken shall also be recorded.
Management review
There shall be a periodic review of the operation of the pharmaceutical quality system with the involvement of senior management to identify opportunities for the improvement of the veterinary medicinal products, the manufacturing process and of the system itself.
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