Services
Existing facilities shall be inspected and suggestions/service will be given to upgrade the facility to make cGMP compliant.
SOME OF THE KYE AREAS OF CONCERN
Facility
Design and modifications to meet regulatory requirements.
Utilities: AHU
Utilities: Purified Water system
Isolator barrier technology for Containment facilities (Oncology)
Manufacturing Process Development
Process Planning & Monitoring
Vendor Development
USFDA Upgradation
USFDA Upgradation
Training
GMP Basics
In-house Seminar
Regulatory Compliance
Technical/Scientific Issues
Quality Assurance
SOP Preparation
Vendor validation
Change control
CAPA
OOS
Rejection and reprocess
Product recall
Annual product review
Site Master File
Internal GMP Audits
Validation
Installation and Operation Qualification
Validation Master Plan
Analytical Method validation
Cleaning Validation
Process Validation
Prepare Validation Protocols
Protocol Implementation
Data Collection/Analysis
Regulatory Compliance
Preparation of DMFs/CTD documents
Prepare responses to 483s
Risk Assessment of Supplies
Drug Master File Preparation
Mock Pre-Approval Inspections
Evaluation of Quality Systems
Untitled Document
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Kkyemistry (India) Pvt. Ltd.
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