sop for Handling of Incident during operation

sop for Handling of Incident during operation   1.0 Objective To lay down a procedure for handling, reporting, investigation and closing of incident during operation. 2.0 Scope This Standard Operating Procedure is applicable for all Incidents during operation and that can directly/ indirectly affect the quality of the product to be followed at formulation plants … Read more

sop for Non Conformance

  sop for Non Conformance   1.0 Objective To lay down a procedure for non conformances observed in all areas of operation and all departments. 2.0 Scope This Standard Operating Procedure is applicable for Non Conformances observed in all departments to be followed at formulation plant of abc Pvt. Ltd. 3.0 Responsibility 3.1 Concerned department … Read more

Batch Numbering System

  Batch Numbering System   1.0 Objective To lay down a procedure for batch numbering system for products. 2.0 Scope This Standard Operating Procedure is applicable for batch numbering system of all dosage forms which includes Tablet, Capsule, Liquid, Lozenges and Dry powder injection for Domestic and Export to be followed at formulation plant of … Read more

Calibration Policy for equipment

  Calibration Policy for equipment   1.0 Objective To lay down a policy for calibration of equipment, instruments, measuring and monitoring device and their documentation. 2.0 Scope This Standard Operating Procedure is applicable for applicable for all the equipment/ instrument / monitoring devices maintained by all departments at formulation plants of abc Pvt. Ltd. 3.0 … Read more

Preparation and Control of Master Batch Production and Control record

  Preparation and Control of Master Batch Production and Control record   1.0 Objective To lay down a procedure for preparation and control of Master Batch Production and Control Record. 2.0 Scope This Standard Operating Procedure is applicable for preparation of Master Batch Production and Control Record of all block to be followed at formulation … Read more

Issuance and Retrieval of Control documents

  Issuance and Retrieval of Control documents   1.0 Objective To lay down a procedure for issuance and retrieval of controlled documents (e.g. SOP, STP, Formats, Printed logbooks, Register, other). 2.0 Scope This Standard Operating Procedure is applicable for procedure of issuance and retrieval of controlled documents like SOP, STP, Formats, Printed logbooks, Register, other … Read more

Issuance and Destruction of Executed Documents

  Issuance and Destruction of Executed Documents   1.0 Objective To lay down a procedure for issuance and destruction of executed documents. 2.0 Scope This Standard Operating Procedure is applicable for issuance and destruction of executed documents at formulation Plants of abc Pvt. Ltd. 3.0 Responsibility 3.1 Officer / Executive QA shall be responsible for … Read more

sop for Procedure for Reprocessing

  sop for Procedure for Reprocessing   1.0 Objective To lay down a procedure for reprocessing. 2.0 Scope This Standard Operating Procedure is applicable for procedure for reprocessing to be followed at formulation plants of abc Pvt. Ltd. 3.0 Responsibility 3.1 Officer / Executive Production shall be responsible for the reprocessing activity. 3.2 Officer / … Read more

Approval of Overprinting on Packing Material

  Approval of Overprinting on Packing Material   1.0 Objective To lay down a procedure for approval of overprinting of packing material. 2.0 Scope This Standard Operating Procedure is applicable for approval of overprinting of packing material of all departments to be followed at formulation plant abc Pvt. Ltd. 3.0 Responsibility 3.1 Officer / Executive … Read more

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