sop for vendor approval of raw materials 1.0 OBJECTIVE: : 1.1 The objective of this SOP is: 1.1.1. To describe a procedure to assess the vendors who can manufacture and supply materials of consistent quality and quantity and at right time 2.0 RESPONSIBILITY: 2.1 The Head – Quality Assurance shall be: 2.1.1. Responsible for auditing … Read more
sop for handling of non conformance incidence 1.0. OBJECTIVE: The objective of this SOP is: 1.1 This procedure defines the responsibilities and authority for handling and investigating non-conformance (NC), for taking appropriate corrective and preventive actions to prevent recurrence of the same. 2.0. RESPONSIBILITY: 2.1 Any employee of the organization shall be: 2.1.1 Responsible … Read more
sop for self inspection and internal audit for quality 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To laid down the procedure to conduct self-inspection (Internal Audit) in order to monitor the implementation and compliance with Good Manufacturing Practices (GMP), Principles and to propose necessary corrective measures. 2.0 RESPONSIBILITY: 2.1 The … Read more
sop for area and equipment clearance procedure OBJECTIVE: 1.0 To describe the procedure for checking of equipment and area before giving line clearance during manufacturing and packaging operation. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance – Officer/ Executive shall be: 2.1.1 Responsible for assuring the equipment and area for free from remnant of previous batch / … Read more
1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for allowing transfer of Finished Goods under “Quarantined status” to our godown. 2.0 RESPONSIBILITY: 2.1 The Head – Warehouse shall be: 2.1.1 Responsible for raising the request for Quarantined Release. 2.2 Quality Assurance Officer shall be: 2.2.1 Responsible for verification and reconciliation … Read more
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