Compliance Services
ASI provides a full range of compliance and validation services for the pharmaceutical, medical device and biologic industries.
Philosophy
ASI's approach to compliance is one that focuses on outcomes and never confuses "rules with principles". ASI believes that the validation process should provide a meaningful increase in the quality and efficiency of our clients' processes.
"Risk Based" has been a buzz word in the industry lately. The Risk Based approach was recently highlighted in the FDA's Final Report on Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach, released in Fall 2004. The FDA's intent with the risk based approach is as follows, "Encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas."
The intent of the above statement is that extra attention should be focused in areas where "manufacturing processes are crucial to the safety of the product (e.g., adventitious agent clearance, inactivation of live product) or when products serve a critical medical need or have a critical public health impact (e.g., products for the prevention of communicable diseases)."
ASI uses this approach in its compliance philosophy by ensuring that the focus of our work is on areas deemed critical to the product. ASI uses a common sense approach to provide testing rigor and documentation detail commensurate with a given product's specifications.
Quality Systems
The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management Quality System - 820.3(v)
The FDA defines the following systems as being critical to maintaining a quality product:
- Quality Management
- Records, Document, and Change Controls
- Productions and Process Controls
- Equipment and Facility Controls
- Corrective and Preventive Actions
- Design Controls
- Material Controls
ASI has broad experience in all these quality systems in terms of implementation, optimization, and automation.
Validation/Qualification
The importance of the planning stage for projects involving validation/qualification cannot be over emphasized. Proper planning results in smooth project execution. ASI has the industry savvy and experience to provide project management and extensive support at the initial stages of a project. ASI can provide:
- Design Reviews
- Validation Master Planning
- Validation Implementation Planning
- 21 CFR Part 11 Gap Assessments
- Risk Assessments
- Feasibility Studies
- Isolation Plans
- Remediation Plans
Once a validation/qualification project is underway, ASI's staff has experience with equipment, facility, utility, computer hardware/software, process, cleaning, and test method validation/qualification in environments from bulk chemical manufacturing to aseptic filling. ASI has validated the following systems for numerous life sciences clients:
- Control Systems
- Aseptic Filling
- Bulk Powder/Liquid Handling
- Sterilization
- Drying/Coating/Granulating
- Tabletting
- Product Contact Glasses
- DW, DI, & RO Systems Purification
- Packaging/Fill/Labeling
- Form/Fill/Seal
- Controls and Instrumentation
- Steam/EtO/Radiation
- Product Containment
- Clean Rooms
- Clean Steam Lyophilization
- Fermentation
- Distillation/Crystallization
- Mixing/Milling
- Stability Chambers
- Coolers/Freezers
- Controls and Instrumentation
- HVAC
Computer System Methodology
Computer systems validation has evolved over the last two decades. In light of the FDA's new "GMPs for the 21st Century Initiative", it is of great importance to provide an efficient, systematic approach to computer system validation. ASI's Computer Systems Validation (CSV) methodology strives to achieve the Three R's; Reliability, Robustness and Repeatability for any application ASI validates. ASI's System Development Life Cycle Methodology (SDLC) is based on GAMP4 and ISO standards.
Training
ASI's training courses are designed to instruct personnel in regulated industries on the intent and implementation of FDA regulations.
ASI can arrange for training facilities or prepare and deliver custom courses on-site at your facility. Our consultants can tailor these training courses to meet your organization's needs.
ASI offers the following training sessions:
| COURSE | HOURS |
| CURRENT GOOD MANUFACTURING PRACTICES, PART I | 4 |
| CURRENT GOOD MANUFACTURING PRACTICES, PART II | 4 |
| PRINCIPLES OF VALIDATION/QUALIFICATION PART I | 4 |
| PRINCIPLES OF VALIDATION/QUALIFICATION PART II | 4 |
| 21 CFR, PART 11 | 4 |
| QUALITY SYSTEM REGULATIONS | 4 |
| PRINCIPLES OF CLEANING VALIDATION | 4 |
| PRINCIPLES OF COMPUTER SYSTEM VALIDATION | 4 |
| SIX SIGMA THEORY | 24 |
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