sop on receipt & storage of dispensed raw materials 1.0 Objective: To describe the procedure for receipt and storage of dispensed raw materials. 2.0 Scope: This procedure is applicable to receipt and storage of dispensed raw materials in production area 3.0 Responsibility: Production Officers / Executive. 4.0 Accountability: Department Head shall be accountable for the … Read more
cleaning of capsule bulk packing machine 1.0 OBJECTIVE To ensure that the cleaning procedure removes residues to extent of compliance with predetermined acceptance level. 2.0 SCOPE This protocol applicable for cleaning of Capsule Bulk Packing Machine. 3.0 RESPONSIBILITY Q.C. Officer , Q.C. In-charge . 4.0 PROCEDURE Clean as per SOP no :—— a) Sampling … Read more
1.0 OBJECTIVE 1.1 To describe the procedure for cleaning and operation of vibro sifter. 2.0 SCOPE 2.1 This procedure is applicable to vibro sifter present in the production area. 3.0 RESPONSIBILITY 3.1 Operator – To perform the procedure. 3.2 Executive production- To ensure that the operation is being performed in compliance with the SOP and … Read more
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 describe a procedure for maintenance of equipment logbook. 2.0 SCOPE 2.1 This procedure is applicable to all equipment used in production sections . 3.0 RESPONSIBILITY 3.1 Concern Officer/Executive shall enter the operation and cleaning details in equipment log book. 3.2 Concern Officer/Executive shall execute this SOP. 4.0 ACCOUNTABILITY 4.1 Department Head … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for Qualification of Outsource Testing Facility. 2.0 SCOPE 2.1 This procedure is applicable to testing the outsource qualification 3.0 RESPONSIBILITY 3.1 Executive – Quality Assurance Department. 4.0 ACCOUNTABILITY 4.1 Head – Quality Assurance. 5.0 PROCEDURE 5.1 Selection criteria 5.1.1 Outsource testing facility should have approved by any regulatory … Read more