Deliverables
- Author SOPs and Test Methods
- Change Control Management
- Compliant System
- Risk-based Validation Plan
- Data Trending
- Testing Execution
- Technical Transfer Assistance
- Employee Training
- Project Management
Benefits
- Improved Efficiency
- Reliable Service
- Tailored to Customer Needs
- Drive Down Costs
- Quality Driven
- Adherence to FDA and Other Regulatory Agency Compliance
- Allows Redeployment of Internal Resources
Quality Compliance
LexaMed 's concept of quality systems involves the synchronization of procedures and processes thus yielding a quality product or device intended for human use. This approach allows us to ensure compliance with cGMP regulations related to drug safety, identity, strength, quality, and purity.
LexaMed provides Quality Management System services compliant with:
►21 CFR Part 820-Quality System Regulation
►21 CFR Part 210/211-GMP in Manufacturing,
Processing, Packaging, or Holding of Drugs:
General/GMP for Finished Pharmaceuticals
►21 CFR Part 111-GMP in Manufacturing,
Packaging, Labeling, or Holding Operations for
Dietary Supplements
►21 CFR Part 11
►EU GMP, Chapters 1-9, Annex 1
►ICH Q7A-GMP for APIs
►ICH Q8-Pharmaceutical Development
►ICH Q9-Quality Risk Management
►ICH Q10-Pharmaceutical Quality System
Quality Management Systems
LexaMed can build a robust quality system encompassing the six specific elements of the quality system to ensure it is in a state of constant control. Quality should be built into the product; testing alone cannot be relied upon to ensure product quality. LexaMed has proven expertise in the following quality areas:
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Quality System ►Effective controls and monitoring tools ►Integrated Systems ►Quality by Design |
Laboratory Controls System ►Laboratory Investigations ►SOPs and Test Method Generation ►CAPA Plans ►Stability Program ►IQ / OQ / PQ ►Specification Generation
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| Production System ►Equipment Validation and Qualification ►Process Controls ►Cleaning Validation |
Packaging & Labeling System ►Specification Generation ►Label Control System ►Contamination Prevention ►Product Inspection Process
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Facilities & Equipment System ►Critical Utilities System Qualification ►Validation of Compressed Air and Gases ►Clean Room Qualification ►Sterilization Techniques
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Materials System ►Incoming Inspection Program ►Supplier Qualification ►Supplier Audits ►Warehousing Procedures
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