sop for handling of non conformance incidence

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

  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

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

sop for quarantined release for warehouse

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

Analytical Method Validation Procedure

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

sop for line clearance manufacturing area and packing Area

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

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

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

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

  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

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