Quality Management System for Active pharmaceutical

More documents

Recommendations

Info

Quality Management System - integrating GMP into ISOChapter 20: Statistical techniquesPrincipleAppropriate statistical techniques should be identified, documented and implemented to controlquality critical processes.20.1 Identification of need20.1.1 The main activities for the application of statistical techniques are likely to besampling plans, stability testing, validation, interpretation of analytical data,identifying process capability and trend analysis. A statistical perspective is essentialwhen planning a complex investigation if maximum benefit is to be derived.20.1.2 API manufacturers should identify and document the need for, and application of,appropriate statistical techniques.20.2 Procedures20.2.1 Documented procedures and adequate training should be used to control theapplication of statistical techniques.20.2.2 Whenever possible recognised published statistical techniques should be selected foruse. If alternatives are applied, their use should be justified through traceability tobasic statistical theory.51
Quality Management System - integrating GMP into ISOAnnex A: HygienePrincipleWhile not directly addressed under the specific heading in the EN ISO 9001 framework asapplied to personnel and to facilities, principles relevant to hygiene are encompassed within therequirements of Process Control (chapter 9) and Training (chapter 18) in order to ensure thecorrect behaviour of those whose activities affect quality. This is exemplified through the needfor qualified, trained personnel to comply with codes of practice, standards and procedures in asuitable working environment.A.1 PersonnelA.1.1Direct contact with API should be avoided.A.1.2Clothing designed to protect both product and personnel should be worn andchanged when necessary.A.1.3Personnel suffering from an infectious disease or having open lesions on the exposedsurface of the body should avoid activities which could compromise the quality ofAPI.A.1.4Smoking, eating, drinking, chewing and storage of food should be restricted todesignated areas separated from production or control areas.A.2 Facilities and equipmentA.2.1Building and equipment should be of an appropriate design to facilitate cleaning andto avoid contamination.A.2.2Changing, washing, toilet and refreshment rooms should be separate fromproduction areas.A.2.3Areas used to store, produce or control raw materials, intermediates, API andpackaging materials should be kept clean and tidy.A.2.4Premises should be cleaned in accordance with written procedures. Sanitation ordisinfection agents and their usage should be specified.A.2.5Product contact surfaces of equipment and connections between equipment shouldbe easily cleanable.52
Page 2: Quality Management System - integra
Page 6 and 7: Quality Management System - integra

Quality Management System for Active pharmaceutical

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?