Quality Compliance Architects

10/05/2023

All most all the major pharma regulatory bodies of the globe have independent guidelines for warehousing and distribution operation of medicines.

Companies doing warehousing and distribution or willing to do the same in those regulated countries or companies doing or willing to do warehousing and distribution of medicines of multinational manufacturers in any country do need to comply with those gdp guidelines of highly regulated bodies (MHRA, FDA, EU, TGA, Health Canada etc).

QCA provides a comprehensive GDP solution that ensures compliance with all international gdp regulations.

To know more, email at [email protected] or call over phone 01684992716.

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30/08/2018

In today's competitive world sustainable growth of your products and services are driven by the assurance of compliance and continual improvement. And so CA is here beside you as a trusted partner to help to ensure compliance and continual improvement of your products and service.

CA is a privately owned company formed in July 2018. It provides innovative consulting, training and service solutions to ensure your compliance ensuring effective operation. The solutions it provides at present are as below:

1. Quality Compliance - We provide Implementation and Certification assistance for -
* Design, Development and Implementation of QMS
* Good Distribution Practices
* Good Clinical Practices
* ISO 9001: 2015 Quality Management System
* ISO 45001:2018 Occupational Health and Safety Management System (OHSAS)
* ISO 1345 Medical Device - Quality Management System
* ISO 1345 Medical Device Risk Management System

2. Training - We provide training on -
- Awareness Training
* QMS
* GDP (WHO, EU, FDA, PICs)
* GSP (WHO)
* GCP
* ISO 9001:2015
* ISO 45001:2018
* ISO 1345
* ISO 14971
* Adverse Event / Pharmacovigilance Management
- Auditing
* Internal Quality Audit
* Internal OHSAS Audit
* Self Inspection
* Handling of Audit
- Quality Tools / Skills
* CAPA Management
* Effective RCA (Root Cause Analysis)
* Why Why / 5 Whys
* 5s
* 4M / 4P
* Incident Management
* Deviation Management

3. Validation: We do validation for you for -
- Warehouse
- Cold Room
- Bio-refrigerator
- Passive Packaging System
- Temperature controlled delivery van
- Entire Cold Chain Mapping
- Temperature Mapping

4. Documentation: We do documentation for you on -
- QMS Manual
- GDP Manual
- Site Master file /Site directory
- Protocol
- Master Procedure / Standard operation Procedure / Work Instruction / Policy / Form
- Flowchart / Business process mapping and process interaction

5. Audit Management - We manage your quality and safety audits as like -
- Audit Planning
- Checklist Preparation
- Internal Quality Audit
- Internal OHSAS Audit
- Supplier / Vendor Audit
- Self-Inspection

6. Other Solutions: Other solutions we serve you
- Quality and Safety GAP analysis
- Quality Risk Management

15/08/2018

Go with compliance, assure your success!