ICH QUALITY STABILITY GUIDELINE
by (1). Q1A (R2)-Stability Testing of New Drug Substances and Products (2). Q1B-Stability Testing ( Photostability Testing of New Drug Substances and Products). (3). Q1C-Stability Testing …
Category: Quality Control
Gap Analysis For Regulatory Complience
Check the list of the documents of the respective department and identify the areas to be analyzed for gap, according to the criticality of the …
Operation of Reverse Laminar Air Flow
To lay down the procedure for operation of Reverse Laminar Air Flow. 2. Scope The SOP is applicable to operation of RLAF in sampling . …
Assigning Expiry Dates to Laboratory Solutions and Chemicals
1.0 OBJECTIVE To lay down the procedure for assigning expiry dates to laboratory chemicals and solutions. 2.0 SCOPE This procedure is applicable for assigning expiry …
Procedure for procurement of primary standard
To lay down a procedure for procurement for primary standard. This procedure is applicable for procedure for procurement for primary standard in Pharmaceutical industries. QC …
COLUMN MANAGMENT
To define the HPLC column performs satisfactorily and gives reproducible results. PROCEDURE: COLUMN OPERATING AND CLEANING: On receipt of the new column put the …
Analytical Method Validation
Method Validation is the process which is established, through laboratory studies, that the performance characteristics of the method meet the requirements for its intended purpose. …
Poor Peak Shape in HPLC
One of the most common peak problems in HPLC is peak splitting or broadening. This can be caused by a variety of factors, (1).column overload, …
Cleaning Validation Sampling in Pharmaceutical
The two main sampling techniques available for cleaning validation are rinse and swab sampling. FDA prefers swab sampling to rinse sampling (4, 5). In many pharmaceutical …
Worst Case Identification in Cleaning Validation
Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment is cleaned thoroughly. In identifying …