Ensure Good Documentation Practices
Good documentation practice is a crucial component of quality assurance, integral to all aspects of Good Manufacturing Practice (GMP). This principle, as outlined by WHO, explains the importance of accurate, clear, and consistent documentation to ensure the quality and safety of pharmaceutical products. Effective documentation practices are essential for complying with regulatory standards such as GLP, GMP, ISO, and FDA requirements.
Implement Efficient
Documentation Practice
Our services encompass all aspects of pharmaceutical production:
Building and Premises: Documentation related to installation, validation, cleaning, and maintenance.
Personnel: Training records, hygiene standards, and compliance documentation.
Equipment: Installation, calibration, validation, maintenance, and cleaning records.
Materials: Specifications, testing, warehousing, usage, and rejection/disposal records.
Processing: Documentation of each step in the manufacturing process, including controls and validations.
Finished Goods: Specifications, testing, storage, distribution, and rejection/disposal records.
Complaints: Investigation reports, actions taken, and documentation of returned or salvaged finished products.
Our services encompass all aspects of pharmaceutical production:
Building and Premises: Documentation related to installation, validation, cleaning, and maintenance.
Personnel: Training records, hygiene standards, and compliance documentation.
Equipment: Installation, calibration, validation, maintenance, and cleaning records.
Materials: Specifications, testing, warehousing, usage, and rejection/disposal records.
Processing: Documentation of each step in the manufacturing process, including controls and validations.
Finished Goods: Specifications, testing, storage, distribution, and rejection/disposal records.
Complaints: Investigation reports, actions taken, and documentation of returned or salvaged finished products.
Our services encompass all aspects of pharmaceutical production:
Building and Premises: Documentation related to installation, validation, cleaning, and maintenance.
Personnel: Training records, hygiene standards, and compliance documentation.
Equipment: Installation, calibration, validation, maintenance, and cleaning records.
Materials: Specifications, testing, warehousing, usage, and rejection/disposal records.
Processing: Documentation of each step in the manufacturing process, including controls and validations.
Finished Goods: Specifications, testing, storage, distribution, and rejection/disposal records.
Complaints: Investigation reports, actions taken, and documentation of returned or salvaged finished products.
An Ongoing
Compliance Framework
Comprehensive Documentation
Solutions
Tailored SOP
Development
Data Integration
for Analysis
Training and
Support
