Phone +49 7621 76176 Mo - Fr 9.00 - 17.00 (GMT)
Master Plans

Validation master plan drug substance manufacturing (API)

Master Plans
170,00 EUR
app. 224.40USD
(Non-german customers)

202,30 EUR
(German customers incl. 19% tax)

What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
GMP Money Back Guarantee
Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after SEVEN ENTIRE DAYS just give us a call, and we'll personally guarantee you get a complete refund.

Description of the Master Plans - Validation master plan drug substance manufacturing (API)

The validation master plan (VMP) is a crucial document as it describes the basic concept for your overall site validation program.

This 26-page VMP template for manufacturers of drug substances/active pharmaceutical ingredients, which has been updated in line with current industry standards, needs only a small amount of site-specific modification before it can be adopted for your operations.

The VMP addresses: process validation, facility qualification and validation, utility qualification and validation, equipment qualification and cleaning validation. Its objective is to outline the principles involved in the qualification and validation of your facility, define the areas and systems that are to be qualified and validated and provide a program for achieving and maintaining validated status.

Table of Content:

1. Introduction
1.1. Background
1.2 Introduction
1.3 Scope
1.4 Responsibilities
2. Description of facility
2.1 General design
2.2 Plant Layout
2.3 Zoning concept
2.4 Pressure differential concept
2.5 Room design
2.6 Processing
2.7 Storage areas
2.8 Personnel
2.9 Personnel Flow
2.10 Material Flow
3. Description of Systems
3.1 Utilities
3.2 Critical Utilities
3.2.1 Portable water
3.2.2 Purified Water
3.2.3 Heating, ventilation and air-conditioning (HVAC)
3.2.4 Compressed air and gases (nitrogen)
3.2.5 Vacuum System
4. Description of Processing Equipment
4.1 General description
4.2 Drying and Milling operations
5. Description of automated systems
5.1 Environment monitoring system
5.2 Process control system
5.3 Alarm Systems
5.4 Temperature and humidity control
6. Products to be manufactured
7. Qualification/validation approach
7.1 Approach
7.2 Acceptance criteria
7.2.1 DQ –general acceptance criteria
7.2.2 IQ –general acceptance criteria
7.2.3 OQ –general acceptance criteria
7.2.4 PQ equipment–general acceptance criteria
7.3 Process Validation – general acceptance criteria
7.4 Cleaning validation approach
7.4.1 Introduction
7.4.2 Rooms
7.4.3 Manufacturing Equipment
7.4.4 Microbiological Monitoring
7.5 Computer Validation
7.6 Calibration
7.7 Maintenance
7.8 Personnel Training
7.8.1 General
7.8.2 Types of training
7.9 Change Control
8. Documentation
8.1 Technical Project documentation
8.2 Validation Documentation
8.3 Document Numbering System
8.4 QA document review and approval
8.5 Operational Documentation (SOPs)
9. Attachments (site specific)
9.1 Plan Layout including equipment
9.2 Floor plan indicating zoning concept
9.3 Pressure differential concept
9.4 Organization charts
9.5 Personnel Flow concept
9.6 Gowning Concept
9.7 Material Flow Concept
9.8 GMP related computer systems
9.9 List of critical Utilities
9.10 List of non Critical Utilities
9.11 Purified water treatment and loop
9.12 List of all equipment detailing size and purpose
9.13 Drawing of air treatment including filters
9.14 Compressed air and gasses drawings for the generation, treatment and distribution loop including filters
9.15 List of SOPs relating to validation and operation
10. Distribution

Validation master plan drug substance manufacturing (API)
170,00 EUR
Additional 19% tax for customers from Germany
Customers who bought this item also bought:
Annual product review
90,00 EUR
15.56% also purchased this product.
Deviations (failure investigations, non-conformance)
85,00 EUR
14.8% also purchased this product.
Handling of chemicals, reagents and solutions in laboratories
50,00 EUR
12.76% also purchased this product.
100,00 EUR
11.99% also purchased this product.
GMP document management
85,00 EUR
8.67% also purchased this product.
Investigation of complaints
100,00 EUR
7.65% also purchased this product.
Supplier audit program
85,00 EUR
7.14% also purchased this product.
Site master file (SMF) for drug products
245,00 EUR
6.63% also purchased this product.
Validation Master Plan Drug Product Manufacturing
200,00 EUR
6.12% also purchased this product.
Site master file (SMF) for API - drug substances
245,00 EUR
4.59% also purchased this product.
PAI protocol for API
195,00 EUR
2.55% also purchased this product.
Qualification master plan for refrigerated shipment
185,00 EUR
1.53% also purchased this product.
Product Recall
120,00 EUR

eCommerce Engine © 2006 xt:Commerce Shopsoftware