Process Consulting
Companies who manufacture cGMP products want to ship the highest quality product possible to their customers. The staff at EXL Laboratories Inc. can make that easy. We can help you understand FDA regulations for good manufacturing practices (cGMP) and make sure you stay in cGMP compliance. Our focus is making cGMP compliance easy and our goal is to help you find reasonable, cost effective ways of meeting or improving your cGMP compliance to meet FDA requirements.
Process Consulting Services
GMP Auditing:
Identify issues before they become problems! An audit can find cGMP compliance issues that can be fixed well before they become problems. We want you to be prepared for FDA inspections or by any other inspector so they have no reason to find fault with your procedures or cGMP compliance. That’s the best way we know to avoid 483 notifications or the potential for having your manufacturing suspended.
Our cGMP experts can evaluate your quality systems and overall cGMP compliance throughout your manufacturing operation. They can point out issues and recommend ways to improve. They will cover everything from the production process to other aspects such as how complaints are handled and records are kept. The quality of your organization will affect the safety and well-being of the customers who enjoy your products so we want you to be at the top of your game.
Quality System Design:
A good comprehensive quality system design can give you a set of cGMP procedures and policies that are integrated and easy to learn and follow. The effort requires designing in coordination between all manufacturing and quality functions and providing processes that flow with the material and the plant. Our experts understand FDA regulations and GMP for dietary supplements, and have been designing quality systems for several decades. They know what is needed and what can work best in your situation.
We can provide expertise and procedures for:
* Organizational structure
* Responsibilities
* Data Management
* Manufacturing Processes
* Resource Management
* Continuous Improvement
* Product Quality
* Maintenance
Standard Operating Procedures:
Our Quality Assurance professionals are experts in developing SOPs that meet FDA regulations and GMP for the Life Science regulated industries. A full set of compliant manufacturing SOPs can be provided and SOPs for facility operations are available on-request. You can get additional quality support for auditing, gap analysis and SOP customization whenever you need without the extra costs of hiring regular full-time employees.
Quality Assurance Support:
Our Quality Assurance professionals are experts in FDA regulations and GMP for Life Science regulated industries. They are available on-demand or on an hourly basis to help with your special projects or overflow needs. You can get additional quality resources when you need them without the extra overhead costs of full time employees.
Our QA experts can help you by:
* Conducting cGMP audits
* Ensuring cGMP Compliance
* Reviewing batch records and recommending disposition
* Providing QA guidance for deviations, investigations and CAPAs
* Writing, reviewing or approving SOPs, specifications, protocols and study reports
* Developing and managing GMP training programs
