Hello,
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Does anyone has any suggestion about selection of a CMO packager process?
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What are the critical elements of maintaining oversight of your CMOs, exactly, how do you monitor their performance?
Any feedback is highly appreciate.
thanks
CONTRACT PACKER SELECTION & QUALIFICATION PROCESS
The following steps are a proven way to select a qualified contract packager for your company:
Step 1: Locate Contract Packagers
Step 2: The Telephone Survey
Step 3: Written Vendor Survey
Step 4: On-Site Visit and Audit
Step 5: Final Evaluation
Step 1: Locate Contract Packagers
Pre-qualify potential contract packagers by considering the following:
[b][COLOR=“blue”]- Location
- Referrals
- Experience
-Equipment - Cost
-Good Communication - Controls
- Financial Strength
- Personality
-Standards - Size
- Quality
- Years in Business
- Full-Time Staffing
-Conflict of Interests - Strong Ethics[/color][/b]
After you have a clear understanding of what qualifications your contract packager should possess, you can begin to collect a list of contract packagers.
Step 2: The Telephone Survey
The next step in the selection process is to call the packagers on your list so you can qualify or disqualify them based on the following…
[COLOR=“darkred”]Location of Facility
Size of Facility
Hours of Operation
Similar Projects or Similar Past Experiences
Similar Existing Customers or Projects
Turnkey Opportunities Available
Inventory Control Systems
Degree of Automation
Hold Special Licenses or Certificates
Years in Operation
Core Specialty or Core Businesses
Top 5 Clients[/color]
Depending on the size of your project and company, you should be down to no fewer than three company names and no more than ten.
You should request literature, brochures, and equipment lists from all those that qualify. In turn, you should send out samples of your product, request a quotation, and send out a Written Vendor Survey
Step 3: Written Vendor Survey
In addition to the questions asked during the Telephone Survey, you may require written verification of the following…
[COLOR=“green”]ISO, GMP, AIB Status and Documentation
Organization Chart
Mission Statement
Safety Record
Proof of Insurance
Financial Statement[/color]
Filter out those that do not qualify and move on to the next step.
Step 4: On-Site Visit and Audit :
Next, if required, you may want to schedule a plant tour, meet key members of the staff, and audit their facility. Questions to ask yourself include…
[b][COLOR=“purple”]Is the facility clean and well organized?
Is there adequate staffing?
Are there adequate procedures and systems in place to meet the expectations of your company?
Are the procedures documented and can the staff clearly explain them?
Look for…
Letters of Recognition or Customer Testimonials
Awards from Customers
Production Samples on Display[/color][/b]
Filter out those that do not qualify and move on to the next step.
Step 5: Final Evaluation
It’s time to select your contract packager! In this step, you should evaluate the information you gathered from the previous steps.You may want to review the following…
[COLOR=“indigo”]Quality Standards
Production Capacity
Project Pricing
Customer Lists
Equipments Lists
Customer Referrals
Management Team
Industry Associations[/color]
Once you have a company or two in mind, ask yourself, “Is this company all that they claim to be?” After all, you and your company’s reputation is at stake since your contract packager will be the last hands that touch your product before it is shipped out to your distribution center or your customer’s warehouse.
After you award your contract to your contract packager of choice, contact the other packagers you were considering and review with them the reasons they weren’t selected.
Regards
Thank you very much, I really appreciate it! That was very helpful. Can anyone else comment on question 2 please?
The CMO’s performance can be monitored by these factors:
- Their reply to your questions with in the time frame.
-Quality parameters in packing with out any deviations.
-How quickly they implements CAPAS raised by you.
-How are desptach timings over a period of 3 months?
-What is the documentation they are doing and sending you regularly?
-What are typical in process controls they follow regularly for your product?
Regards
Thank you very much!!
Essential packaging services a Contract Drug Manufacturing Organization should offer :
[b][COLOR=“black”]I.Pharmaceutical Packaging Services
-Identification and sourcing of relevant packaging options
-Design input to initial concepts
-Packaging specification development
-Formulation and package compatibility assessment
-Proof of concept demonstration
-Packaging equipment sourcing, design and engineering services
-Ballpark commercialization estimates
-Turnkey sourcing services for unique and specialized drug packaging
II. Primary Container Evaluation
-Volume delivery verification per actuation and doses per container
-Spray pattern evaluation
-Dosage repeatability
III. Container Closure Compatibility Testing
-Thermal analysis
-Light transmission
-Water vapor permeation
-Non volatile residue
-Heavy metals
-Extractables and leachables[/color][/b]
A service provider should begin the process by evaluating the chemical background to identify potential compatibility issues. Subsequent steps include review and evaluation of container/closure requirements and evaluation of container/closure form, fit and function. Then, the container/closure should be analyzed to ensure compatibility with the product. The next step in the packaging development process is to create container/closure specifications and assist in documentation preparation for regulatory submissions. At this point, the Contracr Drug Manufacturing Organization should provide packaging instructions or production modules. Engineering studies should be conducted to analyze packaging capabilities and identify critical parameters to be used in packaging validations. If something unforeseen occurs that requires modification, the CDMO should begin analysis and troubleshooting as soon as possible.