Quality Assurance

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, …

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 …

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 …

VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual inspection in order to determine the effectiveness of the systems, system compliance and to identify the opportunities for continual improvement as per current regulatory requirements. SCOPE: This SOP is applicable for conducting virtual inspection of …

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 …

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 …

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: …

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. …

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 …

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 …

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 …

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 …

Clean Room Quiz 6 Question: What is the purpose of an airflow direction test and visualization? Answer: The purpose of an airflow direction test and visualization is to demonstrate that the airflow direction and its uniformity of velocity conform to the design and performance specifications. Question: What are the four …

Clean Room Quiz 5 Question: What is recommended for measuring the supply air volume flow rate in cases where there is local airflow turbulence and jet velocities issuing from an outlet? Answer: It is recommended to use an airflow capture hood that captures all of the air issuing from each …

Clean Room Quiz 3 Question: When need to plan for testing and verification testing should be conducted according to the ISO 14644? Answer: Testing should be carried out at minimum during the following instances: a) In connection with classification according to ISO 14644-1; b) At verification during start-up; c) At …

Clean Room Quiz 2 Question: What is the objective of the air pressure difference test.? Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment. Question: When …

Clean Room Quiz 1 -Question & answers on Clean Room Question: What is the definition of an “airborne particle”? Answer: An airborne particle is described as a solid or liquid object suspended in the air, whether viable or non-viable, falling within a size range spanning from 1 nanometer (nm) to …

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 …

GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance To lay down a procedure for good documentation practices requirements for the compliant, consistent and accurate completion of GxP Documentation. GxP in Pharmaceuticals This Procedure applies to all cGxP documents (electronic and handwritten) used in the manufacturing, packaging, labelling, testing, storage and …

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 …