Summary Outcomes - Trinity College Dublin, the University ... · Summary Outcomes. Copyright of The ... Auditing of CMO’s; Evaluation of Audits Reports by QP’s; • Active/Formal

Summary Outcomes

Copyright of The Compliance Group

Key Areas of Discussion

Duplication of Vendor QMS;Access to MA given by Contract Giver (CG) to Contract Acceptor (CA);Disqualification of CMO’s;Communication Challenges;Mirroring of Deviations & CAPA’s;Auditing of CMOs;QP Release Locations.

Note: There were 43 Sites represented at this session 6 of which are CMO’s/CAs


Discussion points Discussion Outcome

How can one avoid duplication of

Vendor Quality Systems?

Technical Agreement is key. However,

one size doesn’t fit all;

Why Internalise Change Controls?

• Tracking

• Regulatory Impact System (Global

v Local)

Duplication of CMO’s in Contract Giver

• All;

• Significant Events v’s Minor;

Defined in Quality Agreement;

Product Quality/Regulatory

Impact;

Quality of the CMO;

Marketing Authorisation Holder v’s

Marketing Partner;

Compliance File issued to CMO’s



How many duplicate Change

Controls?

Types of Change Controls

duplicated;

• All (11 Sites)

• Majors Only (22 Sites)

Need to ensure all parties are

aligned in terms of what is a major

and/or notifiable;

Establish the baseline at PQR.



Does CG give MA access to CA

as a rule?

Yes if releasing under GMP

Conformity;

No need for Full Access MA if not

releasing;

How many share MA Details?;

• 6 from 43 (14%)



Disqualification of CMO’s; Criteria for Disqualification should

be defined in Vendor Approval

Procedures;

Continuity of Supply Issue;

How many sites have disqualified

a CMO outside the Regulatory

Process?

• 1 out of 43 (2%)



Communication Challenges; Message Heard needs to equal

Message Given;

Communications should be clear

and in writing;



Deviations in the CMO’s systems; How many CG’s mirror Deviations in

their own systems

• Major/Criticals - 15 from 43 (35%)

• Minors - Subjective

How many get no notification of

Deviation?

• No notification - Zero

• Major/Critical - 28 of 37(76%)

How many approve the close out of

Deviations?

• 24 of 37 (64%)

How many CG’s mirror CAPA’s for

Deviations in their own systems

• 7 from15 (47%)



Auditing of CMO’s; Evaluation of Audits Reports by

QP’s;

• Active/Formal Review – 5 from

37 (14%)

CMO Audits

• No review of Corporate Audits;

Access to Audit Report for

Declaration of Conformity of API

(QP Declaration)

• Formally Review (21)

• Informally Review (7)

How much access is given to

CMO of Audit of API Supplier?

• Yes if releasing and request it.



Site of Release; Can you release product from

One Country by QP in another?

1. MIA needed in Country of

Physical Importation;

2. MIA needed in Country of QP

Certification;

3. Laboratory Testing must take

place in an EEA Approved

Facility;

Clinical Testing

• Only need 1 & 2 for Clinical

Testing;

• No retesting after importation.



Site of Release; Example

• MIA Entity = A

• US importation to Dublin Hub

= B

• HPRA consider the Dublin Hub

(B) was importation site so

needed MIA despite being

listed as storage site on MIA

held by A;

• Note - 48hr rule was put in

place to cover in transit within

Ireland in Wholesaling Market,

not import/export activities



IMP QP’s; PSF’s Revisions Control;

• Changes format to Reference

Doc

• Individual elements updated

separately

Documents

Summary Outcomes - Trinity College Dublin, the University ... · Summary Outcomes. Copyright of The ... Auditing of CMO’s; Evaluation of Audits Reports by QP’s; • Active/Formal