OBJECTIVE To define the general requirements for an effective calibration control system to ensure that applicable measuring and test equipment is calibrated and maintained within accuracy limits sufficient for their intended purpose. SCOPE This procedure is applicable for calibration of all equipment /instrument/ measuring devices. RESPONSIBILITY Follow up: Concern Department Officer/Executive Overall responsibility: Concern […]
Quality Assurance SOP
OBJECTIVE: The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork. SCOPE: This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility. RESPONSIBILITY: Marketing: Responsible for Color and Design Production Department: Responsible for mentioning size as
OBJECTIVE : The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria SCOPE : This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable
OBJECTIVE: The purpose of this SOP is to lay down the procedure for men and material movement. SCOPE: This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility. RESPONSIBILITY: Each individual entering into the area shall be responsible to follow the practice.
1.0 OBJECTIVE To lay down the procedure for the visual inspection and statistical evaluation of a batch ( Acceptance Quality Level). SCOPE This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation, coating and packing in the company (XXX Name of the company).
OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of different type of labels ( Label Control) in production department. SCOPE: This SOP is applicable for handling of different type of labelsat manufacturing facility. RESPONSIBILITY: Authorized designee of user department is responsible to maintain thestatus label in department. Head- user
Documentation is an essential part of the quality management system. The laboratory should establish and maintain procedures to control and review all documents (both internally generated and from external sources) that form part of the quality documentation. A master list identifying the current version status and distribution of documents should be established and readily available.
The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry
SOP For Corrective Action and Preventive Actions OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer
Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the