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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 Self Inspection team. Team shall be a cross...

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 criteria or not. Stability comes into focus when the...

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 once and comparing the result with pre-defined acceptance criteria....

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 all factors originating from the ambient area and people...

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 challenge test with 107/cm2 diminuta. Derived from these challenge tests,...

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 design is one in which samples for every factor...

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 zone Zone III Hot dry zone Zone IVa Hot humid/tropical zone Zone IVb ASEAN testing conditions hot/higher humidity   LONG TERM TESTING CONDITIONS   Climatic...

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 of Quality by Design to ensure quality of Pharmaceuticals....

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