SELF-INSPECTION PROGRAMME To describe the procedure for scheduling, conducting a self-inspection activity, and implementing corrective/preventive measures and effective follow-up actions towards the non-compliances observed. DATA INTEGRITY AND DATA RELIABILITY
HANDLING OF EXTERNAL AUDIT OBSERVATIONS AND ITS COMPLIANCE EXTERNAL AUDIT OBSERVATIONS -Compliance shall be filled in proper QMS documents such as CAPA format, Investigation form, deviation, Change control and summary of CAPA shall mentioned in Audit Compliance Report. DATA INTEGRITY AND DATA RELIABILITY
DATA INTEGRITY AND DATA RELIABILITY Data Integrity: The extent to which all data are complete, consistent, and accurate throughout the data lifecycle. Data integrity arrangements must ensure that the accuracy, completeness, content, and meaning of data is retained throughout the data lifecycle. DOCUMENT AND DATA CONTROL PROCEDURE
DOCUMENT AND DATA CONTROL PROCEDURE DATA INTEGRITY AND DATA RELIABILITY
MANAGEMENT OF RAW DATA PURPOSE: To provide a procedure for recording, review, and storage of raw data at manufacturing sites. SCOPE: This SOP applies to all the raw data generated/collected during Warehousing, manufacturing/packaging operations, testing, environmental monitoring, operation and monitoring of equipment and utilities, calibrations, qualification and validation activities, cleaning, sterilization, and any other activity, which involve…
STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS PURPOSE: To describe a procedure for Storage and Disposal of Exhibit Batches of Drug Products. SCOPE: This standard operating procedure (SOP) is applicable to the exhibit batches of Drug Products manufactured and packed in the formulation manufacturing facilities. RESPONSIBILITY: Production: Transfers the exhibit batches to warehouse….
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PROCEDURE FOR HANDLING OF EXTERNAL AUDITS OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of external inspections / audits by the agencies and customers for various products. SCOPE: This procedure is applicable for handling of external inspections / audits. RESPONSIBILITY: Site Head: To welcome auditors at opening meeting. To…
HANDLING OF DATA INTEGRITY AUDIT OBSERVATIONS
AUDIT POINT Warehouse: Pictorial presentation not available in sampling change room (Minor) Manufacturer released /approved label not defaced (Minor) Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor) Dispensing scoop status label not available of cleaned on, previous product, Use up to Most of the tools…
VERIFICATION AND TESTING OF FINISHED GOODS PURPOSE: To provide the procedure for testing of finished Goods at outside laboratory and physical verification to ensure that product is complies with specification criteria. SCOPE: This Procedure is applicable for finished product testing at outside lab and receive at depot. Procedure for Physical verification of finished product is…
In-process checks during Dry powder injection manufacturing & packing (IPQA) Objective: : To lay down a procedure for in process checks during Dry powder injection manufacturing & packing. Scope: This procedure is applicable to formulation Plant of pharmaceutical Industry for in process checks during Dry powder injection manufacturing & packing. Responsibility: IPQA Officer/Executive shall be responsible…
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Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. Accountability: Head – Quality Assurance…
VALIDATION: PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES The purpose of this SOP is to lay down procedure for selection Qualification and approval of Service Providers for Outsourced activities of manufacturing sites This procedure shall be applicable for approving, controlling and reviewing of Service Providers supporting outsourced activities relevant to cGMP systems covered as…
INVESTIGATIONS SOP This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxP, approved specifications and/or procedures. This standard applies to Investigations related to quality related events that occur from cGxP, approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records…
Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity as a fundamental aspect of…
Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project Planning: Create a project plan…
Total Quality Management Practices Total Quality Management Practices (TQMS) the first thing that comes to mind when you think of the word “quality”? The word “quality” has many definitions. Quality can be defined as a characteristic or characteristic, as in the following statement: “They are honest people, and that is a good quality.” They also ask…
HANDLING AND INVESTIGATION OF INCIDENTS Incidents – Any unforeseen event or deviations from approved protocols or standard operating procedures without prior authorization and documentation. Any variance from established specifications or requirements stated in Quality System document, which includes but not limited to SOP (Standard Operating Procedure), BMR (Batch Manufacturing Record) and BPR (Batch Packing Record),…
Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry dates to the finished products manufactured. Scope This procedure shall apply to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry dates to batches of finished product Head,…
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SELF-INSPECTION PROGRAMME SELF-INSPECTION / INTERNAL AUDIT is basically a method of an objective overall review of one’s own operation on aspects that may have on quality effect on quality assurance.
