Responsibilities of the Quality Assurance Department OBJECTIVE : To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation …

OBJECTIVE To lay down the procedure for calibration of the HPLC (Waters Alliances 2695, Separation Modules). SCOPE To ensure that the calibration procedure of HPLC meets the acceptances criteria. This SOP shall be applicable for the HPLC system. (WATERS Alliances 2695 Separation Modules). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control …

OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY  Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF …

Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of  Quality Assurance Department to ensure …

OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during  documenting  data  in  operating  departments (like  Quality  Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads  of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry …

OBJECTIVE : To lay down the procedure for in-process checks during the packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE Inspection of Packaging Materials : The production Officer and QA-Officer shall check that …

Installation qualification for WFI generation plant  RESPONSIBILITES Inspection  Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and …

OBJECTIVE : To lay down the procedure to assign expiry date to a finished product. RESPONSIBILITY : Officer  Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE Manufacturing date : The date of manufacture of the batch shall be the date on which an active ingredient has been …

OBJECTIVE : To lay down the procedure for training and evaluation of QA Officers on SOPs  and cGMP. RESPONSIBILITY : Personnel  who   are  knowledgeable  with   the  subject  by  virtue  of  their qualification and experience. Head -Quality Assurance to ensure compliance. PROCEDURE : All Quality Assurance Officers shall undergo training and …

OBJECTIVE To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY In process Quality Assurance Officer / Executive. ACCOUNTABILITY Head Quality Assurance PROCEDURE START UP Inspect the following …