1. Washing of ComponentsThe washing of components will be validated for each load configuration in the vial washer. Cycle Development Testing and Performance Qualification testing will qualify each washing process. A separate performance qualification and cycle development testing report will be written for each load configuration. The processes will be considered validated when the acceptance …
Transport Validation Sample Protocol
1.0 OBJECTIVE
1.1 To evaluate the effect of transportation on the quality of (Product Name) packed in standard primary and other packaging systems. 1.2 To evaluate the effect of transportation by air on the sterility of material filled into Aluminum containers supplied by M/S [Supplier Name].
2.0 ACCEPTANCE CRITERIA 2.1 The physical status [shape and integrity] of the primary and anothe…
1.1 To evaluate the effect of transportation on the quality of (Product Name) packed in standard primary and other packaging systems. 1.2 To evaluate the effect of transportation by air on the sterility of material filled into Aluminum containers supplied by M/S [Supplier Name].
2.0 ACCEPTANCE CRITERIA 2.1 The physical status [shape and integrity] of the primary and anothe…
An Overview of ISO 14644 Clean Room Classification
The area having controlled airborne particle concentration is considered as the clean zone or clean room. These areas are constructed to minimize the introduction, generation, and retention of airborne particles in the area.
The concentration of particles depends on their diameter; hence the bigger particles will be less in number than the smaller particles in any cleanroom environment.
The airborn…
The concentration of particles depends on their diameter; hence the bigger particles will be less in number than the smaller particles in any cleanroom environment.
The airborn…
Guidelines for Receipt and Usage of Reference Standards and Qualification and Usage of Working Standards
REFERENCE STANDARDS & IMPURITY REFERENCE STANDARDS Reference standards are authentic substances that have been approved by Reference Standards approving authority as suitable for use as Comparison Standards in various tests described in individual monographs and methods of analysis. Wherever possible pharmacopoeial reference standards and impurity reference standards shall be procured. If pharma…
International Health Regulatory Bodies
There are some agencies those are to be followed throughout the world and known for their unique guidelines in the pharmaceutical field. 1. World Health Organization (WHO) 2. International Conference on Harmonisation (ICH) 3. International Organization for Standardization (ISO)
Regulatory agencies of individual countries: Every country has its own agency to control health care products in their count…
Regulatory agencies of individual countries: Every country has its own agency to control health care products in their count…