DATA INTEGRITY AND TECHNICAL ETHICS POLICY
Organization provides high quality products to its customers and considers the protection of the patient as a…
Browsing Tag
QA SOP
38 posts
CROSS CONTAMINATION CONTROL POLICY
Cross Contamination Control:
A formal assessment of the control measures required to accompany new Active…
CLEANING VALIDATION POLICY
Equipment/System/Facility is required to be cleaned post usage of product manufacturing and packaging and…
RESPONSIBILITIES OF QUALITY UNIT
Quality unit is an organizational unit independent of production which fulfils both Quality Assurance and…
VALIDATION POLICY
The facility shall be validated in accordance with the systems, guidelines and procedures established by…
TREND ANALYSIS
Control chart shall be used (Using excel spread sheet) to perform the trend analysis of process parameters and…
CLEANING VALIDATION PROGRAMME
Cleaning Validation Studies shall be conducted to ensure that the cleaning procedures for Type C cleaning are…
VENDOR QUALIFICATION
Vendor qualification in the pharmaceutical industry is a critical process to ensure the consistent supply of…
SOP FOR VALIDATION OF VISUAL CHECKING INSPECTOR
Visual inspection is a probabilistic process and the specific detection probability observed for a given product…
INVESTIGATION OF OUT OF SPECIFICATION (OOS)
Out-of-specification test result: Test result that does not comply with the pre-determined acceptance criteria.