Good Laboratory Practices (GLP)

Good Laboratory practices (GLP) in quality control Quality control laboratory is the part of good manufacturing practices concerned with sampling, specifications and testing and with the organization and documentation which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or … Read more

SOP on Analyst Qualification in quality control

ANALYST QUALIFICATION PURPOSE of ANALYST QUALIFICATION: To lay down the procedure for the qualification of analyst in order to confirm that the newly Joined employee analyst and analyst performing tests in quality control laboratory are adequately qualified to produce reliable and accurate results. SOP SCOPE ANALYST QUALIFICATION: This SOP applicable to Quality Control RESPONSIBILITY: Analyst: … Read more

SOP on handling of Out of trend (OOT)

Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be … Read more

SOP on procurement and handling of working standards

SOP on procurement and handling of working standards Objective:To lay down a procedure for the procurement and handling of working standards. Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location. Responsibility:Chemist or above of QC laboratory shall be responsible for follow the procedure … Read more

SOP on Procedure of volumetric solution preparation and standardization

SOP on Procedure of Volumetric solution preparation and standardization To lay down a procedure for preparation and standardization of volumetric solution. Scope Of SOP: This SOP is applicable for the preparation and standardization of volumetric solutions in a quality control laboratory in a pharmaceutical company name with location. Responsibility: An officer or above of QC … Read more

SOP on Procedure for sampling of raw material

Raw material Pharmaceutical raw materials are the fundamental substances used in the production of pharmaceutical drugs. These materials can be classified into two main categories: active pharmaceutical ingredients (APIs) and excipients. Active pharmaceutical ingredients (APIs) are important components of drugs that actively produce the desired therapeutic effect. They are responsible for treating, preventing, or alleviating … Read more

SOP on calibration of glassware

Objective:To lay down the procedure for calibration of laboratory glassware. Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location. Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP. Accountability:Department Head & QA Head shall be accountable for implementation … Read more

SOP ON PRODUCT RECALL AND MOCK RECALL PROCEDURE

PRODUCT RECALL AND MOCK RECALL PROCEDURE To define the procedure for drug product recall and mock recall. SCOPE This SOP shall be applicable to, Hold or recall of drug products from distribution or market due to certain non-confirmatory aspects or instruction from regulatory agency. Hold or recall of drug products sold in domestic and/ or … Read more

Sop on Corrective and Preventive Action (CAPA)

Sop on Corrective and Preventive Action Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence. Scope : This Standard Operating Procedure shall apply to all corrective and preventive action taken … Read more