QUALIFICATION OF IPQC INSTRUMENTS
GTP FOR MICROBIOLOGY
USER REQUIREMENT SPECIFICATION FOR INJECTABLE
The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with input from Quality Assurance.
STABILITY IN PHARMA
Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity.
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
