BASIC REQUIREMENTS FOR QC

Keywords: QC, materials, records 

A. Adequate facilities
• Trained personnel
• Approved procedures for Sampling
• Inspecting
• Testing starting materials
• Testing packaging materials
• Testing intermediates
• Testing bulk and finished products
• Monitor environmental conditions

B. Sampling:
• Samples must be taken by methods and personnel approved by QC
• Samples of starting materials, packaging material, intermediate products, bulk products and finished products

C. Validated methods:
• Test methods must be validated

D. Records
• Records must be made manually or by recording instruments showing and procedures followed and deviation recorded and investigated

E. Finished product testing
• Ingredients comply with Qualitative and Quantitative tests
• Proper container
• Correct labels

F. Records specifications
• Inspecting and testing materials
• Intermediate, bulk and finished product against specifications
• Product assessment, review and evaluation of product documentation and assessment of deviation

G. Certification by authorized person
• No batch is released for sale or supply without certification by production dept. and QC dept. together

H. Samples retained
• Retained for further examination
• Product must be in final pack except it is in large quantity

Other duties of QC
• To establish, validate and implement QC procedure
• To store reference standards
• Participate in investigation of complaints related to Quality of product
• Participate in environmental monitoring
• Perform all procedures according to written procedures and record
• Stability studies
• Relevant factors include production conditions
• Results of in-process testing
• Manufacturing documentation compliance with specification of finished products
• Examination of finished pack