vii. Persons responsible for the certification/release of sterile products have appropriate access to manufacturing and quality information and possess adequateknowledge and experiencein the manufacture of sterile products and the associated critical quality attributes. This is in order to allow such persons...
ii. Personnel should have adequate qualifications and experience, training and behaviour with a specific focus on the principles involved in the protection of sterile product during the manufacturing, packaging and distribution processes. 解读:人员要求的要素:人员的确认、人员的经验、人员的培训以及人员的行为。
The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable
4.5.3.1 (Passive Medical devices) The raw material components of passive medical devices shall meet the relevant standards and requirements, and the biocompatibility evaluation shall be completed for the parts in contact with human body. In the process of repeated sterilization of reusable sterile prod...
(e.g. biotechnology, classical small molecule manufacturing systems and closed systems). This Annex provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of ...
Annex 1Manufacture of Sterile Medicinal Products Annex 2Manufacture of Biological Medicinal Products for Human Use Annex 3Manufacture of Radiopharmaceuticals Annex 4Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products ...
Packaging Instructions: The packaging materials, including sterile barrier systems, should be clearly described. This section should also provide detailed packaging levels and specify materials used for sterilization and packaging integrity. Reference and Comparison to Similar Products: Information on similar ...
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of…Read More Work Permit System (Safety) 2 years ago Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time ...
Manufacturing (sterile, solid, APIs...) Good Distribution Practice APIs/Excipients Packaging/Packaging Materials Development Regulatory Affairs Computer Validation/IT Compliance Qualified Person (QP) Medical Devices GMP Basic Training Courses Other Manufacturing Areas ...
: Batch Manufacturing Record (BMR) No. : Effective Date :Gupta GD, Garg R, Aggarwal S. Guidelines on General Principles of Validation: Solid, Liquid and Sterile dosage forms. 2008; 6: 28-33.Garg R, Aggarwal S and Gupta GD. Guidelines on General Principles of Validation: Solid, Liquid ...