CRITICAL CONTROL PRAMETERS AND CRITICAL QUALITY ATTRIBUTES IN PHARMA
A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.
PRINCIPLES/FREQUENCIES/ ACCEPTANCE CRITERIA/REFERENCES IN PHARMA
Every activity in Pharma have some frequencies whether it is revision of documents, qualification, validation, stability, Re-testing etc. While Acceptance criteria means numerical limits, ranges, or other criteria for tests that are used for or in making a decision to accept or reject a unit, lot, or batch of a PET drug product.
MEDIA FILL IN PHARMA
A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. Dry Powder Injection Three Piece Injection Ampoules
MISCELLANEOUS DOCUMENTS IN PHARMA
Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
BATCH MANUFACTURING & PACKING RECORDS
Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is called a drug mixture or drug formulation. A drug formulation can be given to the patient in various forms like solid, semisolid or liquid. TABLETS HARDGEL CAPSULES SOFTGEL CAPSULES OINTMENTS ORAL LIQUIDS SACHET […]
USER REQUIREMENT SPECIFICATION FOR CHEMICAL INSTRUMENTS
HOLD TIME STUDY IN PHARMA
During Hold Time Study in Pharma, Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk, and finished products are stored under appropriate conditions. Storage arrangements should not have deleterious effects on the subsequent processing, stability, safety, efficacy or quality of starting […]
SOP FOR IPQA INSTRUMENTS IN PHARMA
By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process tests carried out in the production areas or laboratory for compliance with established sampling and testing protocols, analytical methods, and specifications. While tableting or encapsulating, these tests might be run every fifteen or […]
COMPRESSED AIR QUALIFICATION IN PHARMA
Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil aerosols, and other contaminants, are below acceptable limits and do not contaminate the product. In order to deliver high-quality compressed air at the outlet, air compressor units have an air unit system. It […]
USER REQUIREMENTS SPECIFICATION IN PHARMA
The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required equipment, cleaning and proper maintenance, cGMP, safety, and regulatory requirements necessary to build and fabricate a functional equipment that satisfies the user’s needs in the most affordable way. To submit a price quote […]
