Cleaning Validation Sampling in Pharmaceutical
by The two main sampling techniques available for cleaning validation are rinse and swab sampling. FDA prefers swab sampling to rinse sampling (4, 5). In many pharmaceutical …
Category: GMP
MACO and NOEL Calculation for Cleaning Validation
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. …
GMP / Production / Protocol / Validation
CHECKER VALIDATION PROTOCOL AND REPORT FOR CAPSULE VISUAL INSPECTION
VALIDATION TEAM: Designation Name Signature Date QA Officer Production Chemist Production Manager QA Manager …
SOP FOR GOOD DOCUMENTATION PRACTICE
0 OBJECTIVE To lay down a procedure for good documentation practice in quality assurance, quality control, production and other departments. 2.0 SCOPE This SOP is …
SELF INSPECTION
OBJECTIVE : To provide a guideline for self-inspection of facility by a team of qualified persons to monitor the implementation and compliance with Good Manufacturing …
Audit / Engineering / GMP / Microbiology / Production / Quality Assurance / Quality Control / SOPs / Store / Ware house / Uncategorized
SOP FOR HANDLING OF CHANGE CONTROL
OBJECTIVE To lay down a procedure to describe the handling of change control which include the procedure for initiation, evaluation, review, approval/ rejection of proposed …
Audit / Engineering / GMP / Microbiology / Quality Assurance / Quality Control / SOPs / Store / Ware house
SOP FOR HANDLING OF DEVIATION
OBJECTIVE To describe the procedure for handling of deviations. 2.0 SCOPE This SOP is applicable for any deviation in an established process in all …