purposes on manifolds dedicated to medicinal gases may gas provided that the quality of the latter is at least equal to be acceptable if justified and performed under control. In the quality of the medicinal gas. these cases, the quality of the non-medicinal gas should be at least equal to the required quality of the medicinal gas and GMP standards should be maintained. Filling should then be carried out by campaigns. 15. Repair and maintenance operations (including cleaning and purging) of equipment, should not adversely affect the quality of the medicinal gases. In particular, procedures should describe the measures to be taken after repair and maintenance operations involving breaches of the system’s integrity. Specifically it should be demonstrated that the equipment is free from any contamination that may adversely affect the quality of the finished product before releasing it for use. Records should be maintained. 16. A procedure should describe the measures to be taken when a tanker is back into medicinal gas service (after transporting non-medicinal gas in the conditions mentioned in section 12, or after a maintenance operation). This should include analytical testing. DOCUMENTATION 4. Documentation Addition of some Minor parameters to 17. Data included in the records for each batch of cylinders / 4.1 Data included in the records for each batch of cylinders the list of mobile cryogenic vessels must ensure that each filled filled must ensure that each filled cylinder is traceable to parameters to be cylinder is traceable to significant aspects of the relevant significant aspects of the relevant filling operations. As recorded: filling operations. As appropriate, the following should be appropriate, the following should be entered: entered: Inclusion of a the name of the product; shortened the name of the product; similar list for the date and the time of the filling operations; deliveries of bulk batch number;
purposes on manifolds dedicated to medicinal gases may be acceptable if justified and performed under control. In these cases, the quality of the non-medicinal gas should be at least equal to the required quality of the medicinal gas and GMP standards should be maintained. Filling should then be carried out by campaigns. 15. Repair and maintenance operations (including cleaning and purging) of equipment, should not adversely affect the quality of the medicinal gases. In particular, procedures should describe the measures to be taken after repair and maintenance operations involving breaches of the system’s integrity. Specifically it should be demonstrated that the equipment is free from any contamination that may adversely affect the quality of the finished product before releasing it for use. Records should be maintained. 16. A procedure should describe the measures to be taken when a tanker is back into medicinal gas service (after transporting non-medicinal gas in the conditions mentioned in section 12, or after a maintenance operation). This should include analytical testing. gas provided that the quality of the latter is at least equal to the quality of the medicinal gas. DOCUMENTATION 17. Data included in the records for each batch of cylinders / mobile cryogenic vessels must ensure that each filled cylinder is traceable to significant aspects of the relevant filling operations. As appropriate, the following should be entered: the name of the product; batch number; 4. Documentation 4.1 Data included in the records for each batch of cylinders filled must ensure that each filled cylinder is traceable to significant aspects of the relevant filling operations. As appropriate, the following should be entered: the name of the product; the date and the time of the filling operations; Addition of some parameters to the list of parameters to be recorded: Inclusion of a shortened similar list for deliveries of bulk Minor
consult-manuf-automatic-adoption-pics-130529-comparison.docx