1.0 OBJECTIVE 1.1 To lay down the detailed procedure for the Validation of Analytical Methods / Procedures. 2.0 SCOPE 2.1 This Procedure is applicable for the Validation of Analytical Methods being executed using Chromatographic Systems (For Assay, Related Substances, Residual Solvents, Chromatographic Purity, and Content Uniformity etc.), Rate, Particle Size, Viscosity etc. in the Quality … Read more
1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for line clearance from QA before commencement of new or further processing steps. 2.0 SCOPE 2.1 This SOP is applicable for line clearance from QA before commencement of new or further processing steps 3.0 RESPONSIBILITY 3.1 Officer / Executive – Quality Assurance … Read more
sop for monitoring of temperature and humidity 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for monitoring of temperature & humidity of different area where monitoring of temperature & humidity is required. 2.0 SCOPE 2.1 This SOP is applicable for monitoring of temperature & humidity of different area of production … Read more
sop for out of calibration 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for handling of out of calibration instruments. 2.0 SCOPE 2.1 This SOP is applicable for handling of out of calibration instruments 3.0 RESPONSIBILITY 3.1 Officer –Quality assurance-Prepare the SOP and follow-up the SOP accordingly 3.2 Asst. … Read more
sop for receipt issuance retrieval and destruction of rubber stereo 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for Receipt, Issuance, Retrieval and Destruction of Rubber Stereo. 2.0 SCOPE 2.1 This SOP is applicable for Receipt, Issuance, Retrieval and Destruction of Rubber Stereo 3.0 RESPONSIBILITY 3.1 Executive-Quality Assurance – Prepare … Read more
sop for calibration and handling of standard weights 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for calibration & handling of standard weights using for calibration of electronic weighing balances. 2.0 SCOPE 2.1 This SOP is applicable for all the standard weights handled and maintained 3.0 RESPONSIBILITY 3.1 Officer … Read more
sop for calibration policy 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for calibration & maintenance of equipment, measuring and monitoring device along with desired documentation as per cGMP norms. 2.0 SCOPE 2.1 This SOP is applicable for all the equipment / instrument handled and maintained 3.0 RESPONSIBILITY 3.1 Officer … Read more
sop for stability policy 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for stability study policy for formulated products because quality of a formulated product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Study enables recommended storage conditions, … Read more
sop for cleaning validation in pharma 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for cleaning validation. 2.0 SCOPE 2.1 This SOP is applicable for cleaning validation 3.0 RESPONSIBILITY 3.1 Executive –Quality Assurance – Prepare the SOP and follow-up the SOP accordingly. 3.2 Asst. Manager –Quality Assurance -Provide the support … Read more
sop for validation plan 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for validation plan. 2.0 SCOPE 2.1 This SOP is applicable for validation plan 3.0 RESPONSIBILITY 3.1 Executive -Quality Assurance – Prepare the SOP and follow-up the SOP accordingly. 3.2 Asst. Manager –Quality Assurance -Provide the support to … Read more