Pharma Quality Desk - PQD

 Dear friend's Hope all of you are doing well....! Schedule M has been received and notified on 28th December 2023. There are many changes as compare to previous version. The revised schedule M is divided into thirteen parts. In coming days I will provide the summary of these changes in this site for your easy reference. This change impacts all the pharmaceutical manufacturing plants in India. See you...

  General Cleaning Methods and Concepts Cleaning methods are broadly divided in to three types (1) manual cleaning method (2) Semi-automated  cleaning procedure & (3) fully automated system. whatever the cleaning method used for cleaning, it is necessary that each cleaning procedure should be fully documented and controlled. The standard operating procedure shall be available for each type of cleaning methods. The documentation should include a clear and unambiguous definition of its intended scope and applicability. This includes definition of a processing equipment and products to which it is applies. For example a clear distinction must be made between an abbreviated cleaning procedure designed for use between batches of the same product and a rigorous cleaning procedure designed for use between batches of different products. In some cases it is best to dedicate the use of some equipment's to certain products. For example filter bags used in FBD. By dedicating the some ...

Good Laboratory Practices and Requirement of premises and Equipment's General Requirements:- a) The laboratory or the the organization of which it is a part must be an entity that is legally authorized to function and can be held legally responsible. b) Management ensures that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements.  c) The Quality manger shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensures the maintenance of documented quality systems as per quality manual. Premises:- a) The laboratory shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination. b) Wall, floor and ceilings ( interior surface) shall be smooth and free from cracks and permits easy cleani...

  GENERANL APPEARANCE Size, shape and thickness Size and shape:  Can be controlled by size and shape of punches and die of tablet compression machine. Tablet thickness (dimensional variation) related to: a)        Constant compression load:  Tablet Thickness varies with tab. weight, die fill and Particle Size distribution. b)       Constant die fill: Thickness varies with compression load. Tablet thickness can be measured by: Micrometer:  Measure individual tablet thickness (so accurate information on variation between tab.) Holding tray: measure total tab. thickness of 5-10 tablet with a sliding caliper scale (not accurate information provider on variation between tabs but overall estimation) to give more rapid readings. Shape: Shape of tablet influence the choice of tablet machine used with special slotted punches that run at lower speed than conventional punches that produce round tablets. Organ...

Survey has been done for importance for training effectiveness.  95% people are agreed that training effectiveness is important for any training imparted to employees. Thank you all for participation of above survey.

  Quality Assurance (QA)   is a wide ranging concept concerning all matter that individually or collectively influence the quality of a product. It is the totality of the arrangement made with the object of ensuring that products are of the quality required for their intended use.  The QA department is responsible for ensuring that the quality policies adopted by a company are followed. In some organization, QA serves as the primary contact with regulatory agencies and is the final authority for product acceptance (release) or rejection.  QA to play a major role in the identification, preparation and implementation of the necessary standard operating procedures (SOPs) relative to the control of quality. Where QA has responsibility for final product release, it must determine that the product meets all the applicable specifications and that it was manufactured according to internal standards and cGMPs. A second major responsibility of the QA department is the monitori...