Colorcon, no-tox products general questionnaire response booklet




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COLORCON, NO-TOX PRODUCTS GENERAL QUESTIONNAIRE RESPONSE BOOKLET

Colorcon, No-Tox Products Division is committed to providing superior products and services that exceed our customer’s expectations. We are dedicated to continuous quality improvement and regulatory compliance.


In an effort to further serve our valued customers, Colorcon NTPD has compiled a general questionnaire response booklet. This booklet is a compilation of customer questions and our responses as gathered over the last few years. The booklet allows for a rapid turnaround for customer questionnaires, an overview of our division and a list of contacts for your convenience.
Since 1967, No-Tox Products has been the world’s leader in the manufacture of direct-food-contact-compliant inks and coatings, as well as inks for imprinting medical devices and medical or pharmaceutical packaging.
Colorcon No-Tox Products is a division of the privately held Colorcon, Inc., 1936 West Point Pike, P.O. Box 24, West Point PA 19486. NTPD is located at 171 New Britain Boulevard, Chalfont PA 18914. Our main telephone number is (267) 695-7700 and our fax number is (267) 695-7799.


COMMONLY ASKED QUESTIONS





  1. Purchasing and Receiving of Materials

Are Certificates of Analysis (C/A) provided by our suppliers for each shipment? Yes


Are there adequate systems and procedures in use for receipt of purchased materials? Yes
Do procurement documents (e.g. contract agreement, P.O.) reflect material codes, Yes

drawing, specification requirements, and/or Certificate of Conformance?

(Note: Packaging supplies do not have COC’s, but each vendor does comply with

stated specs.)
Is there a written agreement whereby the supplier agrees to notify Colorcon of any Yes

proposed change in raw material and/or manufacturing process?

(Note: An updated letter guaranteeing ongoing compliance with this agreement has been sent to each of our suppliersfor signature in April, 2007.)
Are history records kept for each supplier? Yes
Are any of our raw materials obtained via reclamation or recycling processes? No
Are raw materials processed prior to their expiration dates? Yes*

(* When possible. If expiration date has passed, material may be retested to



determine if use would not affect properties of our finished products.)


  1. Manufacturing


    1. Process Controls

Is there a batch/run/lot production and control record system used in manufacturing? Yes


Is traceability to raw material lot and component raw materials protected through the Yes

manufacturing process?


Does NTPD have an established Master Production and Control Record system? Yes
Is production equipment in all phases of production dedicated to one specific product? No*

(* This is not possible in our type of operation. All products are custom



manufactured to order in a batch process. Cleaning procedures have been esta-

blished in such a way as to minimize chances for contamination.)
Is there an employee/visitor dress policy for special areas? Yes
Is the equipment constructed such that all surfaces that come in contact with chemicals Yes

shall not be reactive, additive, or sorptive?


Is there a water treatment system? Yes
Is there a monitoring program to ensure that process water is maintained at quality Yes levels appropriate for our intended uses?
Have you validated your manufacturing processes? Yes

    1. Process Instructions/Specifications

Are there written manufacturing/process instructions/specifications to assure process Yes

repeatability and control?
Are there procedures for making changes in manufacturing specifications? Yes
Are such changes approved and documented by designated individuals? Yes
Is any approved change in the manufacturing process communicated to appropriate Yes

personnel in a timely manner?


Do you notify customers of any significant change to your process prior to implement- Yes

ting such changes?


Do you notify customers if a change is made to your process that would impact speci- Yes

fication requirements?





  1. Storage and Distribution




      1. Material Storage and Handling

Are stock rooms and/or material storage areas restricted to authorized personnel? Yes


Are materials properly labeled to prevent errors in issuance? Yes
Are there procedures for the control and issuance of materials? Yes
Are materials stored and handled in a manner designed to prevent damage, mix-up, Yes

contamination, and other adverse effects?


Are there procedures and controls in place to ensure cross-contamination does not occur Yes

of materials being stored or transported in reusable containers?

(Note: We specify that re-conditioned drums/containers are not be used for the raw materials that we purchase.)

Is non-conforming material promptly identified and segregated? Yes


Are the environmental conditions adequate for raw material and finished goods to Yes

assure material stability?


Are there controls in the delivery system to the customer so as to prevent the dispensing Yes

of product into incorrect storage units?


Is final product held in quarantine or otherwise controlled until it is officially released Yes

for sale?




      1. Packing and Labeling Controls

Is there an individual(s) designated to proofread labels and other labeling for accuracy Yes

prior to use?
Are labels stored and maintained in a manner that provides identification and prevents Yes

mix-ups?
Is there a system for assuring that only current labels are retained and obsolete labels Yes

destroyed?
Do un-inspected or nonconforming products become quarantined and cannot be Yes

inadvertently shipped?


Is all labeling on finished products checked for accuracy? Yes
Are there written instructions to ensure proper unit count, and that the product is Yes

packaged so as to avoid transportation damage?





  1. Quality Control Function



      1. Sampling/Testing of Raw Materials

Area raw materials inspected, sampled, and tested for conformance to specifications? Yes



(All raw material lots are sampled and subjected to FTIR identification tests. Every

fourth lot of a given raw material undergoes afully battery of physical/chemical tests.)

Are there written raw material sampling and testing procedures? Yes


Do the sampling plans incorporate statistical risk? Yes
When material is approved on vendor’s certificates of analysis (C/A), is there periodic N/A

verification testing of this data?

(We do not use a Vendor C of A as a full-acceptance criterion for the products we buy.)
Are raw material inspection and disposition records kept for a period of time? Yes

(Comment :Kept for a minimum of seven years from receipt date.)
Are test records with disposition properly stored? Yes
Does the supplier retain raw material samples? Yes
Does NTPD retain raw material samples? Yes
Are there written disposition criteria and procedures for the acceptance/rejection Yes

of raw materials?


Are obsolete, rejected, or deteriorated raw materials clearly identified and segregated Yes

from accepted materials?


Does a qualified individual(s) accept/reject raw materials? Yes
Are records adequate for traceability to suppliers’ identifications and specifications? Yes


      1. In-Process Inspection

Are there written specifications and/or procedures describing in-process testing Yes

and test methods?
Are the individuals performing the tests formally trained to perform such functions? Yes


      1. Final Product Testing/Inspection

Is there a finished product inspection for each product made? Yes


Do all products have current material specifications? Yes
Is there an analytical laboratory or physical testing laboratory available to do Yes

such testing?


Is the laboratory of proper design and adequately equipped ? Yes
Does the Q.C. Department operate independently from the manufacturing/operations Yes

department?


Does the laboratory incorporate the use of scientifically sound test procedures Yes

(A.S.T.M. or similar) and standards?


Are tests performed to ensure that ALL requirements of the specification are met? Yes
Are test methods written with adequate detail so as to minimize the chance for Yes

analyst error?


Can you provide a customer with copies of your test methods, upon request? Yes
Are finished products identified as approved for shipping? Yes
Are there written acceptance/rejection criteria and procedures describing test methods? Yes
Is final inspection /testing performed either by or under the surveillance of a Quality Yes

Assurance or Quality Control group?


Does the QC/QA unit have the final authority to accept or reject finished product? Yes
Are records of inspection and test data maintained, and for how long? Yes

(Minimum of seven years.)
Are retain samples of all batches maintained, and for how long? Yes

(Maintained for about three years.)


Prior to release, are all acceptance records crosschecked by a designated individual(s)? Yes

(QC/QA personnel audit all batch and test records before any product can be released

to our shipping department.)
Do records include or refer to the location of manufacturing, the date(s) of manufactur- Yes

ing, the quantity for shipment, and the control number used?


Are Certificates Of Analysis indicating conformance with specifications generated for Yes

each manufactured batch?




  1. Quality Assurance Function




      1. Quality System

Is Colorcon NTPD ISO-certified or have any intentions to pursue ISO certification? No



(Colorcon NTPD adheres to the current Good Manufacturing Practices

(cGMP’s) based upon those established by IPEC for Bulk Pharmaceuitcal

Chemical Suppliers and by the FDA for food manufacturers as per 21 CFR,

Part 110and medical device manufacturers as per 21 CFR Part 820.)
Does your facility have a formal QA program and/or Inspection Plan? Yes

Are procedures documented and revision controlled? Yes


Is a QA Manual and/or Inspection Plan approved by Company Management? No

(NTPD does not have a quality manual , but procedures are structured in a

quality manual format.)
Does the QC/QA unit have the final authority to accept or reject materials? Yes
Where training programs are necessary to assure that personnel have a thorough Yes

understanding of their job, are such programs conducted and documented?





      1. Rejections and Complaints

Is there a documented system to respond to returns and customer complaints, and for Yes

taking corrective action to prevent problems from recurring?
Is an organized complaint file describing follow-up actions maintained? Yes


      1. Calibration and Measurement of Equipment

Is all QC and Production measurement equipment routinely checked, calibrated, and in- Yes

spected according to a written procedure?
Do calibration procedures provide specific tolerance ranges? Yes
Are the calibration dates, the calibrator, and the next calibration date recorded and Yes

displayed, or are records containing such information readily available for each piece

of equipment requiring calibration ?


d. Regulatory

Can NTPD provide certification that all materials used in No-Tox inks and coatings Yes

comply with specific requirements established by the FDA in appropriate sections of

Title 21 of the U.S. Code of Federal Regulations (21 CFR)?Can NTPD provide regulatory information regarding the following topics as they apply Yes

to your individual products?


  • BSE/TSE

  • Proposition 65

  • Ozone Depleting Substances

  • BATF Approval

  • NAFTA Origination

  • Toxic Packaging Reduction Act (with respect to heavy metal content)



  1. Maintenance



i.Environmental Control, Cleaning, and Sanitation

Does the manufacturing facility provide adequate space to prevent mix-ups or Yes

contamination?
Are there facility cleaning procedures and schedules? Yes
Is there an insect and rodent control program? Yes

(Only materials suitable for use in food manufacturing facilities are used for insect

and rodent control.)
Where environmental conditions (i.e. air handling, temperature, humidity) at the manu- Yes

facturing site could have an adverse effect on a product’s fitness for use, are these en-

vironmental conditions properly controlled?
Are there periodic, documented inspections of these controls to verify that the systems Yes

are functioning properly?


Are there written cleaning procedures and schedules for manufacturing equipment? Yes
Are personnel suitably dressed where a lack of suitable attire could adversely affect Yes

the product?




  1. Maintenance of Equipment

Where maintenance of equipment is necessary to assure manufacturing specification are Yes

met, is there a written schedule for maintenance, adjustment, and cleaning of equipment

which is adhered to?

Is such a schedule visibly posted on or near each piece of equipment affected, or is it at Yes

least readily available to personnel performing such activities?


Is there a written record maintained which documents when activities were performed Yes

to assure adherence to applicable maintenance schedules?


Are any limitations or tolerances visibly posted on or near equipment requiring periodic Yes

adjustments or at least readily available to maintenance personnel?



Note: Manufacturing and cleaning procedures note all criteria to follow to assure


repeated equipment cleanliness between batches.


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