GOOD MICROBIOLOGY LABORATORY PRACTICES To provide general guidance on Good laboratory practices in microbiology laboratory consisting of activities that depend on several principles, aseptic techniques, control of media, control of test strains, and control of equipment’s, personnel hygiene, health and garments. SCOPE GOOD MICROBIOLOGY LABORATORY PRACTICES: This SOP is applicable for Microbiology lab. RESPONSIBILITY: Concerned … Read more
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 … Read more
GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS General Requirements OF GLP :- The laboratory or the organization it belongs to must have legal authorization to operate and be held accountable under the law. The management is responsible for ensuring that the laboratory conducts its testing, calibration, validation, and other technical activities in compliance with Good … Read more
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 … Read more
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 methods used for performing the … Read more
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 final filter or supply diffuser. … Read more
![[ays_quiz id='19']](https://pharmaguidances.com/wp-content/uploads/2023/08/quiz.jpg "Clean Room Quiz 3 5")
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 verification after failures have been … Read more
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 should the air pressure difference … Read more
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 100 micrometers (μm). Question: How … Read more
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 … Read more
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 distribution of Drug Products and … Read more
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, … Read more
Internal Audit and Self Inspection Internal Audit: An onsite verification of activity used to determine effective implementation of documented quality systems. Self-Inspection : Verification of departmental activity used to determine effective implementation of documented quality systems. Objective To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices … Read more
Preparation, Approval and Control of Specifications and Standard Test Procedures Objective To lay down a procedure for the preparation, approval and control of Specifications and Standard Test Procedures for raw materials, packaging materials, in-process materials and finished products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of all Specifications and Standard … Read more
Preparation, Approval, Review, and Control of Technical Directions for the Manufacture of Drug Products Objective To lay down a procedure for the Preparation, Approval, Review, and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of Technical Directions for all products manufactured at … Read more
HOLD TIME FOR DISPENSED MATERIAL, INTERMEDIATES AND FINISHED PRODUCTS The purpose of this SOP is to describe the systematic procedure to establish the hold time of Dispensed materials, intermediate and bulk product prior to final packing. This SOP is applicable for Dispensed materials, intermediate as well as bulk product hold time study. REFERENCE(S) & ATTACHMENT(S) … Read more
QUALITY AGREEMENT OF MANUFACTURE AND SUPPLY This Manufacture and Supply Agreement is made and executed on this ___ day of _________ 202__ (“Effective Date”) By and Between First Part , a company incorporated under the Companies Act, 1956 having its registered office at __________________________________________ and its corporate office at ___________________________________________ or meaning thereof be deemed to … Read more
Guideline for Process Validation To define the procedure for exhibit batch monitoring and process validation of drug products for meeting all the predefined attributes and the process is capable of consistently delivering quality products. This involves the collection and evaluation of data from the process design stage through commercial production to establish scientific evidence that … Read more
GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance In the complex and dynamic world of pharmaceuticals, ensuring the quality, safety, and compliance of products is of paramount importance. GxP, a set of regulations and guidelines that govern various aspects of pharmaceutical manufacturing, plays a critical role in maintaining industry standards. This blog explores the significance … Read more
Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in formal stability studies? A: The … Read more
