CHANGE CONTROL IN PHARMA
Change control:- Change control is a strategic activity to bring about changes in document/process/method. It can be for the smaller period of time or it…
Tag: Quality Assurance
DEVIATION
DEVIATION:- Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and…
SELF INSPECTION OF PREMISES
A systematic inspection program to detect any shortcomings in the implementation of cGMP and to recommend necessary corrective actions. Manager QA/Head QA shall nominate the…
STABILITY STUDIES IN DRUG DEVELOPMENT PROCESS
INTRODUCTION:- Stability study is a vital stake of the drug development process. Stability is the only way that assures whether the drug is within acceptance…
QUALIFICATION PROCEDURE FOR WEIGHING BALANCES
Verification:- Verification of the balance is performed by placing a suitable weight (depending on the type of balance) in the center of the weighing pan…
EXTERNAL FACTORS IN WEIGHING PROCESS
All balance parameters presented in here are related to typical laboratory conditions, that is the ones which take interfering factors into account. The term includes…
FILTER INTEGRITY TESTING
Integrity tests, such as the diffusive flow, pressure hold, bubble point, or water intrusion tests, are non-destructive tests, which are correlated to the destructive bacteria…
BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Introduction:- A full study design is one in which samples for every combination of all design factors are tested at all time points. A reduced…
ICH STABILITY ZONES
Four climatic zones can be distinguished for the purpose of worldwide stability as follows: Zone Type of Climate Zone I Temperate zone Zone II Mediterranean/subtropical…
QUALITY BY DESIGN (QBD)
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use…
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