SOP on Operating procedure for tap density apparatus make : electrolab

OBJECTIVE To lay down the procedure for Operation of Tap density apparatus, Make Electro lab. SCOPE This SOP shall provide the Operating procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation Check for the area cleanliness and instrument cleanliness. Connect the … Read more

SOP on Operating procedure for sieve shaker in quality control

SOP on Operating procedure for sieve shaker in quality control OBJECTIVE To lay down the procedure for Operation of Mechanical Sieve Shaker, Make Electro Lab. SCOPE This SOP shall provide the Operating procedure of Mechanical Sieve Shaker of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control. ACCOUNTABILITY Head QC/QA. PROCEDURE Check the cleanliness of … Read more

Procedure for calibration of Instruments/ Equipments.Quality Assurance

OBJECTIVE : To lay down policy for calibration of Instruments/Equipments. RESPONSIBILITY : Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. There shall … Read more

SOP On Installation, Operational and Performance qualification of Equipment

OBJECTIVE :      To lay down the procedure for Installation, Operation and Performance qualification of Equipment. RESPONSIBILITY :             Validation team comprising of representatives from functional department,   Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. PROCEDURE    Any equipment or instrument purchased shall … Read more

Preparation, Approval and Control of Standard Cleaning Procedures for equipments

Preparation, Approval and Control of Standard Cleaning Procedures for equipments OBJECTIVE :             To  lay  down  the  guidelines  for  the  preparation,  approval and control of Standard Cleaning  Procedure (SCP) for all the applicable equipments. RESPONSIBILITY :     All the personnel  involved in the cleaning of equipments. Heads of concerned departments to ensure compliance. PROCEDURE Every   equipment  … Read more

SOP On Document and Data Control

Objective:To lay down a procedure for control of documents and documented data. Scope:This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow this SOP for maintaining control on all documents and documented data … Read more

Preparation, Approval, Review and Control of Standard Operating Procedures

OBJECTIVE:     To lay down the procedure for the preparation, approval, review and control of Standard Operating Procedures. RESPONSIBILITY:    All the personnel of  all department to be familiar with this Standard Operating Procedure (SOP). The approving authorities to ensure compliance to the preparation, approval and Review procedure. Head – QA or his designee to ensure controlled distribution … Read more

Process Validation: General Principles and Practices (January 2011)

INTRODUCTION The principles and approaches that all manufacturers can use to validate manufacturing processes. This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonization (ICH) guidance’s for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept … Read more

Stability Study

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