Joint Committee on Pharmaceutical Excipients
Draft Meeting Summary
Providence, RI
April 27, 2017
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I Opening Remarks
Joint Committee (JC) Chairperson Brian Zamora welcomed everyone and called the meeting to order. Rachel Brooker read the antitrust statement and completed roll call. Quorum was not reached so R. Brooker explained that if a motion is those on the call can vote but she will have to send out an email after the meeting to conclude voting on that motion.
II Review of Agenda
B. Zamora requested the group to review the April 2017 agenda for approval. David Klug requested to add a discussion on how to reach quorum at the next meeting and generally increase participation. R. Brooker confirmed that she was going to cover that in the membership review. Irwin Silverstein suggested to have an update on the remapping of the standard to ISO 9001: 2015. R. Brooker added that topic.
Motion: D. Klug motioned to accept the proposed agenda.
Seconded: I. Silverstein
Objections: None
Abstentions: None
Vote by verbal affirmation: None apposed.
III Review of 2016 Meeting Summary
B. Zamora asked if there were any additions or corrections to the April 28, 2016 Joint Committee on Pharmaceutical meeting summary.
Motion: C. Moreton motioned to approve the 2016 meeting summary.
Seconded: Katherine Ulman
Objections: None
Abstentions: None
Vote by verbal affirmation: None apposed.
R. Brooker reminded everyone that she will send out an email to complete the quorum and that those who are in attendance for the meeting do not need to answer the email since they already voted.
IV Membership Review
R. Brooker presented that the JC has 14 members. The breakdown is that there are 6 industry, 6 users, and 2 public health. She was concerned about the lack of public health and pressed the importance of increasing that number.
Since there were not a lot of issue papers to go over the JC decided to do a thorough membership review by going name by name down the roster. R. Brooker asked if there were any name, company, or email changes to each person. R. Brooker noted that she had reached out to Anne Gayot three times and has not gotten a response from her. C. Moreton stated that he knew her and that he will contact her. R. Brooker brought up again the importance of getting more public health representatives. Marla Phillips from Xavier was mentioned but R. Brooker replied that she already contacted her and Marla said that she was too busy. Someone was going to reach out to her again to see if any of her colleagues had time to participate. When R. Brooker got to Walter Joppy’s name it was questioned if he was in the correct category because Johnson & Johnson uses excipients in their final product but they do not produce them. R. Brooker agreed with that statement and noted that she would have to consult the application and how it is written since she is not the one who created it. Moving on to David Klug it was also questioned if he was industry. I. Silverstein informed the group that he is now an independent consultant (IBS Consulting in Quality) and needed to be changed. R. Brooker confirmed his email. K. Ulman also changed to consulting (KLU Consulting). C. Moreton mentioned that he is a professor at a university and therefore would qualify to be a public health member. B. Zamora approved of changing C. Moreton to public health based on his teaching position. He also approved of changing W. Joppy and David Klug to user.
Once the JC finished the going through the roster, R. Brooker opened the application to review how it lists users and industry members. The group decided to make the changes listed below. This is not something that is under the prevue of the JC so it does not require a motion and vote.
Industry: A member who produces, assembles, distributes, or sells materials, products, systems, or services covered in the scope of the standard. Industry trade association representatives are included in this membership classification. Examples of this category include: Distributor, Industry Trade Association, Manufacturer of products covered by this Standard; refrigeration and vaccine, Manufacturer Processes, Vaccine transporter NSF/IPEC-AMERICAS/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
□ Public Agency/Regulatory: A member who is from a public agency. Examples of this category include: Government, Military, Model code organization, Professional public/environmental health/safety organization, Public agency having regulatory authority for Products in this Standard NSF/IPEC-AMERICAS/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients, Teaching and Educational Institutions, Non Profit Research Organizations.
□ User/Consumer: A member who purchases, uses, or specifies materials, products, systems, or services covered in the scope of the standard. A member who represents an organization that provides for-profit services applying to the scope of the Standard. Examples of this category include: Hospitals, Pharmacies, Consumer, Standard developer Third Party Certifiers, Training provider, Clinical specialist; Health Care Professional; Nurse; User of products or systems covered by this Standard, User/consumer Trade Associations
V New Issues
A. PE-2017-1 Section 8.2.4.5 (363i11)
Discussion: I. Silverstein presented the issue paper stating that this came up at an IPEC-AMERICAS meeting because some people were confused by the original statement meant. After discussion the JC settled on the changes below.
The Certificate of Analysis shall include, at a minimum:
— excipient name (trade name), and, if applicable, grade, and compendial name and compendial reference, or reference to the excipient specification;
— organization’s name, contact information and identity of the site of manufacture. If the site of manufacture is not detailed on the Certificate of Analysis then this information shall be communicated separately;
— date of manufacture;
— batch number;
— expiration date or retest date, and, if previously retested, the date it was retested;
— statement of conformance to the required specification;
— statement of compliance to GMP as defined by this Standard (may be otherwise communicated with the customer);
— analytical results representative of the batch; if not based on testing of a sample of the finished excipient the basis of the results shall be communicated to the customer, (see NOTE below for alternatives to finished excipient testing, as appropriate);
— acceptance criteria;
— reference to the analytical method used; and
— name and title of person whose physical signature appears on the Certificate of Analysis or electronic signature statement.
Motion: K. Ulman motioned to send the above text to ballot.
Seconded: I. Silverstein
Objections: None
Abstentions: None
Vote by verbal affirmation: None apposed.
R. Brooker reminded everyone that she will send out an email to complete the quorum and that those who are in attendance for the meeting do not need to answer the email since they already voted.
VI Task Group Update
A. Aligning to ISO 9001: 2015 TG
Discussion: Since I. Moore had to sign off the call early, R. Brooker presented on behalf of this task group. She noted that at the 2016 face to face meeting the JC wanted to investigate mapping to ISO 9001:2015. A task group was formed and met but they were not able to develop a plan to map to it. R. Brooker stated that the group wanted to have Bill Sinex, who is an expert on ISO 9001: 2015 help with this remapping. Sinex’s first priority however is the Global Retailers and Manufacturers Alliance (GRMA) has turned into a full time job for him and he has not been able to spare anytime to do an in depth analysis of this standard. The JC wanted to have the TG give the mapping one more try without Sinex especially not that EXCiPACT has remapped to ISO 9001: 2015. R. Brooker will work with I. Moore, chair, to schedule a meeting.
VII New/Other Business
B. New Business
Discussion: B. Zamora asked for any new business but there was none.
C. Next Meeting Date
Discussion: R. Brooker was disappointed in the limited number of meeting participants especially in person. She reminded the JC that they voted last year to have the standing date to be the day after Excipients Fest in the same area of the tradeshow so that everyone would know years in advance when the meeting was going to be. It was suggested to have the meeting directly before or after an IPEC-AMERICAS quarterly meeting.
Motion: C. Moreton moved to cancel the current standing date and to wait each year until the IPEC-AMERICAS quarterly meetings schedule is released in September the prior year. The JC will then be polled to see if just before or after an IPEC-AMERICAS meeting or after the ExcipientFest would give the largest attendance.
Seconded: D. Klug
Objections: None
Abstentions: None
Vote by verbal affirmation: None apposed.
R. Brooker reminded everyone that she will send out an email to complete the quorum and that those who are in attendance for the meeting do not need to answer the email since they already voted.
VIII Adjournment
Motion: C. Moreton motioned to adjourn the meeting.
Seconded: I. Silverstein
Objections: None
Abstentions: None
Vote by verbal affirmation: None apposed.
Motion Passed.
The meeting was adjourned.
Action Items:
1. R. Brooker will send an email out to complete quorum voting to approve of the 2016 meeting summary.
2. R. Brooker will change K. Ulman and I. Silverstein’s company names.
3. R. Brooker will change W. Joppy and D. Klug to user.
4. R. Brooker will amend the application.
5. R. Brooker will send an email out to complete quorum voting to approve of balloting 363i11 as written above.
a. She will hold off sending it to ballot though until the Aligning to ISO 9001: 2015 TG meets and remaps the standard.
6. R. Brooker will work with I. Moore to schedule a meeting for the Aligning to ISO 9001: 2015 TG.
7. R. Brooker will send an email out to complete quorum voting to approve of C. Moreton’s motion regarding the annual face to face meeting.
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Meeting Participants
Joint Committee Members in Person
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Secretariat, Rachel Brooker (NSF)
Chris Moreton (FinnBrit Consulting)
Katherine Ulman (Dow Corning)
Joint Committee Members via Phone
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Chairperson, Brian Zamora
Dale Carter (Huber Engineered Materials)
David Klug (Sanofi)
Iain Moore (Croda Europe Ltd.)
Irwin Silverstein (IPEA, Inc.)
Steven Wolfgang (FDA)
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