2. • Standard Operating Procedures should be in place for every operation
• Standard Operating Procedures should be reviewed and approved by QA
• Standard Operating Procedures should be issued and controlled by QA
• All Quality related documents should be reviewed and approved by QA
• All Master copies of Quality related documents should be retained by QA
• User copies of documents should be issued to user departments by QA
• All approved lay outs like plant lay out, Equipment lay out, Instruments lay out, etc,,
should be available with QA
• QA should ensure compliance with the approved layouts
• QA should issue required controlled formats to user departments as and when required
3. • QA should review the executed formats and retain for future reference
• All deviations from approved procedures, approved layouts should properly be
identified, reported, investigated and CAPA implemented.
• All changes to approved procedures, approved layouts, approved facilities, approved
materials, approved suppliers etc., should be properly identified, reported,
investigated and CAPA implemented.
• All out of Specification situations should properly be identified, reported, investigated
and CAPA implemented.
• All Customer Complaints should properly be registered, investigated and CAPA
implemented
• All return materials and Product Recalls should be properly registered, investigated
and CAPA implemented.
• QA should review the effective implementation of CAPA
4. • QA should review executed BPCR and approve
• QA should review the analytical work sheets
• QA should study the trends of Quality and Yield parameters and investigate any out of
trend situations pro-actively and implement CAPA
• QA should review the product quality annually considering all the factors effecting the
quality and quantity of product.
• New employees should undergo induction training and certification by QA
• All employees should undergo periodic training as per training schedule
• QA should maintain all training records
• Every employee should undergo pre-employment medical examination
• Every employee should undergo periodic medical examination
5. • QA should co-ordinate validation studies such as Process Validation, Method Validation,
Cleaning Validation.
• QA should co-ordinate all Qualification of equipment such as Installation Qualification,
Operational Qualification and Performance Qualification before put to use
• QA should preserve all Validation & Qualification Protocols and Reports for future
reference
• QA should plan internal audits and co-ordinate external audits
• QA should develop and approve vendors. Conduct vendor audits to improve vendor’s
performance.
