Manufacturers shall identify and plan the production, installation and service processes that directly affect quality, and shall ensure that these processes are implemented under controlled conditions.
The controlled conditions referred to in the preceding Paragraph shall include the following:
(1) Where the absence of certain production, installation or service procedures would adversely affect quality, said procedures shall be established in writing.
(2) Suitable production, installation and service facilities shall be used in a suitable work environment.
(3) Relevant laws, standards, and quality plans or documented procedures shall be complied with.
(4) Suitable process parameters and product characteristics shall be monitored and controlled.
(5) Where necessary, processes and facilities shall be approved.
(6) Workmanship criteria (e.g. documented standards, representative samples or illustrations) shall be stipulated in a clear and practical manner.
(7) Facilities shall be suitably maintained to ensure continuing process capabilities.
Where process results cannot be fully verified through subsequent product inspection and testing (including manufacturing deficiencies that only become apparent with product use), said process shall be carried out by qualified operators, or the parameters of said process shall be continuously monitored and controlled, to ensure that specified requirements are met.
Conditions required for process operation, including relevant facilities and personnel, shall be stipulated.
Article 126. Where contact between personnel and products or the production environment could adversely affect product quality, manufacturers shall establish in writing and maintain regulations governing personnel health, cleanliness and attire.
Manufacturers shall ensure that all temporary personnel required to work under special conditions receive necessary training or work under the supervision of trained personnel.
Article 127. Where medical devices meet the following conditions, manufacturers shall establish in writing requirements for the environments to which said devices are exposed:
(1) Said devices are sterile at time of supply.
(2) Said devices are not sterile at time of supply, but require sterilization prior to use.
(3) Removal of microorganisms or dust, or other environmental conditions are critical to the use of said devices.
(4) Environmental conditions during the production process are critical to said devices.
Where necessary, environmental conditions shall be controlled or monitored.
Article 128. Where products meet the following conditions, manufacturers shall establish in writing product cleanliness requirements:
(1) Said products are cleaned by the manufacturer prior to sterilization or use.
(2) Said products are not sterile at time of supply, but require cleaning prior to sterilization or use.
(3) Said products need not be sterile at time of use, but their level of cleanliness is critical to usage results.
(4) Agents used in the manufacture of said products require removal.
Where necessary, products cleaned in accordance with regulations of Subparagraph 1 and Subparagraph 2 of the preceding Paragraph may be waived from the special requirements regarding control of personnel and production environment prescribed in the preceding two Articles.
Article 129. Manufacturers shall establish in writing and maintain requirements for maintenance and repair activities where said activities may affect product quality. Maintenance and repair records shall be kept and maintained.
Article 130. Where necessary, manufacturers shall establish operational guidance documents and acceptance criteria regarding the installation and inspection of medical devices.
Installation and inspection records made by manufacturers or their authorized representatives shall be retained.
Where contracts do not require manufacturers or their authorized representatives to take responsibility for product installation, those who purchase said products shall be provided with documented installation and inspection instructions.
Article 131. Where computer software is applied in process control, manufacturers shall establish in writing and maintain procedures for the validation of said software application. Records shall be kept of validation results.
Article 132. Where medical devices require sterilization, manufacturers shall subject said devices to a validated sterilization process; records shall be kept of all control parameters involved in said sterilization process.
0 Response to "Production Process Control"
Post a Comment