PharmaState Is Official Media Partner For DUPHAT 2022. Click the banner to explore more...spot_imgspot_imgspot_img

Validation of Clean Room Pass Boxes

(A) Clean Room: A Clean Room is an area in which the quantity and size of air- borne particles are controlled in order to limit contamination. A Clean Room is constructed and operated in a...

Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA

Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances                          CATEGORY                             TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Pharmaceutical Quality/Manufacturing Standards (CGMP) Current...

Pharma Regulations and Guidelines-India, Easy Access Links

(1). Regulations & Guidelines:              CDSCO    Central Drugs Standard Control Organization (CDSCO), under MOHFW (Ministry of Health & Family Welfare), Government of India - provides information about Drug & Medical Devices regulatory requirements in India.             NPPA   Drugs...

GUIDELINE ON GOOD MANUFACTURING PRACTICES (GMP) IN PHARMA

  GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to GMP are safe, properly identified, of the...

VALIDATION OF STERILE PACKAGE INTEGRITY

Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may be validated indirectly (e.g., using methods for detecting physical...

PROCESS VALIDATION: GENERAL PRINCIPLES AND PRACTICES

General Considerations for Process Validation: - In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the process validation program more effective and...

ANALYTICAL INSTRUMENT QUALIFICATION (AIQ) 1

AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. PHASES OF QUALIFICATION ...

Recent posts

Popular categories