Home
Contact Details DOCUMENT SHOP
Introduction.
Doc Applications
Validation Enquiry
Site Statistics
Site Problems
Phone; 703-9035
 Free Newsletter
Contact Us Directly.
Linked Sites
Protocols & Plans: Agency Reviewed
Autoclave Validate
Computer Validation (CV)
Combined IQ-OQ-PQ
Compressed Air Val
Computer Vendor Audit
Design Qualification
Facility Qualification
HVAC Qualification
Combined_IQ-OQ
IQ OQ PQ Protocols
Installation Qualify
LAN Validation
Operation Qualify
Performance Qualify
Process Qualification
Spreadsheet Validat
Software Validation
Steam Quality
Temp. Mapping
User Requirements
Validation Plans.
Val. Master Plans
Validation Packages
Procedural Docs: FMEA for Bio-Med
Gap Analysis Tool
cGMP
Predicate Rules
Risk Assessment
SOP for SOP
SOP for cGMP Rev
SOP Validation
Validation Matrix
Vender Audit.
Hard Ware/Copy BSI Standards
Contracted Validate
Data Loggers
Ear Wax Removal
Fridge Guard
Quality Manual (CQM)
Humidity Calibration
Validation Manual (CVM)
Tele Conference
Technical Info: Calibration
CSV Annex 11
Free Vendor Audit
GAMP 5
Glossary
GMP (cGMP's)
GMP Problems.
Hardware Validation
Med Devise Validate
Mixing
21 CFR Part 11
Part 11 Update
Pharma Maint'ance
Protocol Standards
Validation Protocols.
Validation Blog
Video News
Retro-Validation
Warning Letters
Your Free Glossary
General Info: Calculators For All
Conditions of Use
Corpus Clock
Customer List
Easy Business
house
Procedures
Product for License
Regulatory Authorities
Scottish Gifts
Document Shop
Blocked Ear
Installation Validation
Operational Qualify


TELEPHONE ASSISTANCE NUMBER.

Contact telephone assistance number for fast prompt assistance.


1-315-703-9035

Outside Office hours please email to:



help@validation-online.net





Compliant Documentation.

In the qualification of equipment and processes, precise and properly scoped documentation is mandatory.
 
Validation Documentation, such as, (URS, DQIO, OQ, P1Q, P2Q
 
However, there are many manufacturing processes that produce a product or part of a product that cannot be tested (Compliant Documentation.) without damaging it, or indeed destroying it.  The introduction of QA allowed manufacturers to build and destructively test, then using rigorously enforced quality controls replicate the tested product exactly, now knowing its performance and limitations.  Pharmaceutical, biopharm and medical device companies must demonstrate to the regulators that their whole operation is under similar control.  Quality Control that will ensure all operations are documented, all materials are verified as correct and all equipment is qualified as fit for purpose.  
 
All this Compliant Documentation must be in place and in operational use, prior to receiving regulatory approval to manufacture.  This status must be maintained to a standard that ensures consistent replication of all the production processes and without ever compromising the quality of that product.  The maintenance of these standards is called continued Good Manufacturing Practices’ (cGMP).  This qualified or approved state is subject to continuous ministering and inspection by the regulatory authorities involved, as long as the product is in production.


TELEPHONE ASSISTANCE.