An ECA Foundation Interest Group
European
Qualified Person
Association
Tool Box
– Version 1.0 –
September 2014
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Product
Product Name
Article Number
Batch Number
Batch Record Number
:
:
:
:
Page:
Explanation: √= oK; ο= missing, not correct; n.a. = not applicable
Incoming
date:
sender:
Check
Format (Good Documentation Practice –
Conformance):
- Record complete
- Paging correct
- Readable entries and corrections
- additional records attached, paged and readable
- Thermo paper copied and signed
- Fields not used on the form are crossed out
- Entries dated and signed
- All necessary signatures
- Attachments are paged and listed
Content:
- Batch manufacturing procedure approved
- Batch record complete
- Manufacturing information given (dates, yield),
Due date:
Result
Remarks
X of n
- Compounding
 Ingredients, intermediates and packaging material
with article number and batch number
Quality Control records/ analytical batch records
available
Manufacturing
- Work Preparation (Equipment, Material)
- Initial weight print outs
- Initial weight double check
- Identity samples taken
- Equipment
(equipment used recorded, equipment ready for
use?)
- process data:
 comply with requirements
 comply with attachments (cross-reference!)
 attachments correct
- IPC – Data:
 comply with specifications
 if OOS, additional documentation availabel (Doc.Nr.)
 comply with attachments (cross-reference!)
 attachments correct
- Labels:
 content correct
 balancing correct
- Holding times documented
- Yield calculated
- Yield within specification
Deviations
- Deviations documented and evaluated by Head of
Production
- Deviation process initiated (Doc.-Nr.)
Result
Remarks
Review of
Result
Remarks
- equipment cleaning and approval
- room cleaning and approval
- Room temperature, humidity and air pressure data
Delivery receipt
-
drum- number/-name or amount of product
-
signatures complete
- Product Quality Review:
Data transferred
3.1.2
Example Checklist 2
Product .………........................................................................................................
Batch.no ...........................................................
A. Conformity with Marketing Authorisation / Registration Certificate
1
2
3
4
The product name is as specified in the Marketing Authorisation / Registration
Certificate
Manufacturing formula is the authorized one
Expiry data is the authorized one
Steps of manufacturing process performed as required
5
All approved controls was performed. Testing was conducted in accordance
with approved specifications for intermediary, bulk and finished product
6 Finished product testing results are compliant with the acceptance limits stated
in the approved Bulk Product Specification/ Finished Product Specification
7 The labeling is consistent with the Marketing Authorisation / Registration
Certificate. On the batch records they are attached samples of printed
packaging materials used
8 Leaflet is the latest version authorized by Marketing Authorisation /
Registration Certificate
B. Conformity with GMP
1
2
3
4
Batch processing/ packaging records are available and provide the history of
batch
Batch processing/ packaging records include the dates and times for beginning
and completion of the manufacturing steps
Batch processing/ packaging records signed by the responsible personnel and,
where appropriate, for ckeck of major manufacturing steps
All manufacturing operations were conducted in accordance with applicable
approved procedures
DA
Yes
NU
No
NA
Not
applica
ble
5
Starting/ packaging materiales used come from approved suppliers
6
Starting materials and packaging materials were tested in
accordance with approved specifications and have been released
for manufacturing by the responsible persons
7
Manufacturing formula is correctly calculated and starting
materials batch numbers used are documented
8
9
10
11
12
Approved, applicable procedures have been used
The manufacturing process has been validated
Yields obtained are within the limits set
Equipment used is qualified
Reports for monitoring the environmental conditions as stipulated in
the approved procedures are attached
Sterilization reports of equipment / parts used are attached
Testing methods have been validated
Deviations were recorded and investigated according to the
applicable procedure
OOS results were recorded and investigated according to the
applicable procedure
The changes implemented have been approved
A program to monitor the stability is implemented and results are
available
All reference samples and relevant samples are available at all
times
Batch Records have been assessed by Head of Production and Head
of Quality Control
13
14
15
16
17
18
19
20
Comments:
...............................................................................................................................................
...............................................................................................................................................
...............................................................................................................................................
...............................................................................................................................................
...............................................................................................................................................
Checklist for Review of Batch Documentation
Product Name:
Dosage strength
Batch No.:
PL Number:
If “no”, fill in justification/ remarks below
Batch Documents
Batch documents equivalent to Master Documents
All records comply with the rules of Good Documentation practice (SOP xyz)
All entries have been made in the correct data fields
Batch Manufacturing Instructions
Line clearances (equipment/ area) carried out
Strat up tests carried out and verified
All challenge tests carried out
All in-process checks (IPC) carried out at correct intervals
Print-outs for IPC are attached and numbered
All IPC within specification
Process yields are correct and within acceptable limits or justified
Identification/ cleaning labels are attached
Time limitation of each production step within acceptable limits
Raw data accurate?
Batch Packaging Instructions
Line clearances (equipment/ area) carried out
Product and packaging material identification approved
Strat up tests carried out and verified
All challenge tests carried out
All in-process checks (IPC) carried out at correct intervals
Print-outs for IPC are attached and numbered
All IPC within specification
Representative sampling of each pack type and size
Yield and reconciliation correct and within acceptable limits
Correct batch number and expiry date on primary and secondary packaging
PIL/Carton is correct and pertains to product
Transit Temperature Data Report
Report attached
Deviations/ OOS
All deviations logged and justified
Deviation reports available
Did OOS results occur?
If yes, check if OOS documentation is available and complete
Change Control
Did Changes occur?
If yes, check if Change Control documentation is available and complete
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Additional Requirements for Sterile Products:
Checklist for Review of Batch Documentation
Product Name:
Dosage strength
Batch No.:
PL Number:
If “no”, fill in justification/ remarks below
Additional Documents for Sterile Products
All necessary reports available like environmental reports, sterilisation cycle
reports, lyophilisation cycle reports, filtration integrity testing reports
All records comply with the rules of Good Documentation practice (SOP xyz)
Was batch included in any stability, environmental program or validation
exercise?
Records for sterility testing available?
Yes
No
Product:
Description
Investigational
medicinal
product:
* EudraCT
number:
* Study protocol
code, and Centre
Dosage form:
Pack size:
Batch:
In charge:
Date of
manufacture:
Planned
release:
Expiry date:
o placing
o release regular
o clinical trial
o stored until processing
o release quarantined
* If known
No.
01
Request:
Application of the sponsor for the conduct of the trial is available
02
Manufacture and testing instructions in accordance with IMPD
03
Manufacturing and test record are in accordance with
manufacturing and testing instruction.
Randomisation code is correct
04
05
06
07
08
09
10
11
Manufacturing and testing record are dated and signed by the
Head of Manufacturing and Head of Quality Control.
Selected storage and transport conditions are suitable.
Deviations occurred in the production have been documented,
investigated and closed.
OOS occurred during the testing have been documented,
investigated and closed.
Planned changes are approved and if necessary, reported to the
authority.
Starting materials were only used if released by the QC.
12
Raw materials and packaging materials were used, which were
obtained by approved, qualified suppliers.
Critical manufacturing and test methods are validated.
13
Relevant manufacturing and testing equipment are qualified .
Result:
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
No.
14A
Request:
A valid manufacturing license is available.
14b
A valid GMP certificate is available.
15
Contract manufacturer and laboratories are audited/ qualified.
16
18
The current PQR shows no negative trends or other indications of
risk to the overall product quality.
The review of the follow-up stability revealed no indications of
deviations from the specification.
Other factors affecting the quality of the product are not known.
19
The required retention and reference samples are stored.
20
The batch was entered in the release register.
17
Result:
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
o does o does not
o not applicable
Comments:
Result:
o complies with all the above points, batch can be released
o lack of at the following points:
Measures:
o no release and destruction
o quarantine and the following measures:
Check list
completed by:
__________________________________________________________________
______
Product (name, strength, dosage form)/
Batch Number
Intermediate product/ Bulk product in original packing material/
Bulk product/ Deliverable/ Finished product
No. Document
QA
Note
review/
Initials
1
Specifications, analytical methods – API,
excipients, packaging materials
2
Specifications-intermediate and finished
product
3
Quality/Technical agreement
4
Approval of clinical trials from the medical
products Agency (the equivalent of
authority) as well as Ethics Committee/
5
Approved Clinical Trial protocol
6
Randomisation list/key
7
Approved receiver of product
8
Manufacturing Standards; Date; Signatures;
Calculations; Process controls/parameters;
Deviations; Labels; Local Conditions; IMPD
9
Packing Instructions: Date; Signatures;
Calculations; Process controls/parameters;
Deviations; Labels; Local conditions/
10 CoA: results from QC: analytical methods;
Validation of methods; Date; Signatures;
Calculations; Deviations; OOS
11 Stability data / Data for shelf life/retest
period and storage conditions
12 Shelf life and storage conditions/
13 Packaged product
Other Notes/ Other comments :
QP
review/
Initials
Report number: ___________
Name of the product:
Internal code:
Batch size:
Batch number:
Date of production:
Number of the
work order:
Date of the beginning of the
production:
Expiry date:
Date of finishing of the
production:
Documentation of packaging process
Document
Present (√)
Date
Present (√)
Date
Filled protocol of packaging
The work order of packaging process
MONITORING
Sample of packaging material
Primary packaging ( t °C i % RH)
yes 
no 
Secondary packaging ( t °C i % RH)
yes 
no 
Analytical dossier / Documentation of Quality Control
Document
Aluminum foil
Certificate of analysis of packaging
material
PVC or PVdC foil
Boxes
Leaflets
Intermediate
Certificate of analysis
In Bulk
Report of analysis of a finished product
Certificate of analysis of a finished product
Quality report / OOS
yes 
no 
Document
Present (√)
Documentation of Quality Assurance
Quality report / deviations if any and undertaken preventive
and corrective actions
yes 
no 
Approval of proposed changes
no 
Notes:
QP responsible for batch realise to the market:
Date:
yes 
Date
Supplier:
Supplier categories identified in the table that follows may be used to assign an initial risk category.
However, they are subject to change based on a review of intended use (risk), frequency of use
(volume), quality history, previous use, and so on.
Risk
Criteria
Example(s)
High
Medium
Low
Has direct impact or data
provided contributes to a
decision in terms of:
a. Patient safety
b. Product / data quality
c. Product efficacy
d. Personnel safety, or a
e. Regulatory requirement
 Has in-direct impact or
data indirectly contributes
to a decision in terms of
any a-e item listed, or
 A regulatory requirement
is involved, however it
does NOT have a direct
impact on any a-e item.
No direct impact or indirect
impact on non-vital or any ae listed item, or there is no
regulatory requirement.




Contract Research Organizations (CRO)
Contract Research Laboratories (CRL)
Contract manufacturers, laboratories, and packagers
Software and/or service suppliers generating data for
regulatory approval submission
 Consultants that assesses data, specimens, or other
study-related materials and provide contributing scientific
reports and there are secondary Pharmaxyz checks to
detect defects
 Provider/supplier of indirect impact database, software
and related support services
 Provider of materials, such as active ingredients;
comparators; excipients; printed materials; and primary
terials
 Warehouse or distributor of finished clinical supplies
 Provider that supports non-clinical studies and does not
generate, measure, or assess data or study materials
 Provider of network, hardware and related support
services with no impact on safety, quality or efficacy
 Suppliers of biological test systems

-the-shelf items
or blank labels systems
 Animal, animal feed, and bedding supplier
 Supplier and / or distributor of materials such as
secondary packaging
General risk assessment questions
Yes
1
Have clients identified problems, issues or concerns? If yes, explain:
2
Has/will a new technology, product or process been/be introduced? If yes,
explain:
Are there new or revised regulatory / compliance requirements that apply
which need to assessed? If yes, explain:
Have service(s) have been transferred or been assumed? If yes, explain:
Has there been a change to any existing process or service requirements? If
yes, explain:
Do business risk issues exist that need to be assessed? If yes, explain:
Does the CRO, CRL or consultant assess data, specimens, or other studyrelated materials, under the control of a study director?
Does the suppliers quality assurance unit review the data and/or a
subsequent report that is generated?
Will the supplier provide low risk materials only?
Is there evidence of satisfactory audits by regulatory bodies / second-third
parties?
Is the supplier used, known or recognized as a supplier to the
pharmaceutical industry?
Has the supplier been audited by a sister-division?
Were the results of the audit satisfactory for QA intended use?
Has there been an ownership, management, or quality system change?
Have the results of prior audits identified problems, issues or concerns? If
yes, explain:
Does verification of corrective actions from previous audits exist?
3
4
4
5
6
7
8
9
10
11
12
13
14
Since the last evaluation or quality history review…
+
15
Has the volume of studies, study related work, contracted work,
product procured, and so on remained about the same (NC),
increased (+), or decreased (-)?
16
Has there been a change in the rate of non-conformances or
deviations? (e.g., about the same, increased or decreased).
17
What audit type was last performed?
___ Not applicable
Quality History
Second / Third Party Audit
Questionnaire / Self-Assessment
Sister-division evaluation
Pre-screening interview
Comments / description of other:
Certifications (describe)
On-site audit
Other (describe)
No
N/A
NC
N/A
18
19
20
21
22
23
How long has the supplier been used?
When was the supplier last used?
How long has the supplier provided the
product or service to Pharmaxyz?
The rating of the last audit was …
When was an audit last performed?
Was corrective action requested of the
supplier? Describe if yes. If no,
explain:
Description / explanation:
High
<2 years
>5 years
<2 years
Med
2-4 years
2-4 years
2-4 years
Unsatisfactory
Restricted
>5 years
Inadequate
2-4 years
In-process
(not verified
as effective)
Not effective
Assignment of the supplier volume-risk category
For the known/predicted volume, the supplier is:
The overall supplier risk is:
Comments:
High
Low
>5 years
2-4 years
>5 years
Satisfactory
2-4 years
Closed
Verified
Medium
Low
Use the Audit Type Table below to select the audit type(s) based on the overall supplier risk
determined. Record the audit type(s) in Section B of the Risk Based Audit Decision Tool.
When using the table:





The table represents minimum expectations
“Yes” designates an accepted audit type
Quality History applies to existing suppliers only
More than one audit type can be selected, and
Use of an audit type other than that indicated, or designated as “No” is allowed. However, its use
requires documented rationale and justification for use, and
Audit Type Table
Audit Types
Quality History (existing supplier only)
Questionnaire / self-assessment
Sister-division evaluation
Pre-screening (documented interview)
Second-Third Party Audits
Certifications
On-Site Audit
Other
Low Risk
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Audit Frequency
A supplier determined to be…
Low Risk
Medium Risk
High Risk
Has a time period between audits of…
4 years
3 years
2 years
Comments:
Medium Risk
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
High Risk
Yes
No
Yes
No
No
No
Yes
Yes
Section A
Supplier Name:
Date of request:
Address:
Phone:
City / State / Province / Region:
Fax:
Country:
E-mail / Website:
Name/Area Requesting Audit:
Department:
Extension:
What is the planned use for the supplier? (e.g., the product or service to be provided):
Target date / quarter that the supplier is intended to be used:
Is the supplier being used for a specific project and/or study? Yes
name:
_ Phase 1, 2 3 or Pivotal
Phase 4
No If yes, list project/study by
PMOS (Post Market Observational
Study)
Project Number:
Study Number:
Other:
What is the anticipated volume of product or service? (number of studies, sites, batches, tests,
patients, etc.)
Are any of the following available or in-place? Review them, if applicable for quality considerations it
(they) may contain.
Master Services Agreement
Preferred Supplier
Quality Agreement
Technical Agreement
Request for Capital Expenditure (RCE)
Other (describe):
Section B
The supplier is categorized as:
Low Volume / Low Risk
Low Volume / Medium Risk
High Volume / Low Risk
High Volume / Medium Risk
The audit frequency is 4
The audit frequency is 3 years
years
Perform the following:
On-Site Audit
Quality History Existing
Sister-division audit
supplier only
Preliminary / prescreening
interview
Second-Third Party Audits
Low Volume / High Risk
High Volume / High Risk
The audit frequency is 2 years
Certifications
Other (describe):
Questionnaire / SelfAssessment
Functional area(s) to perform the
CBS
GCP
GLP
GMP
audit:
Estimated Audit Travel Cost:
Compass Charge #
Approval
Initiator
Date
Printed Name
______________________________
_____________
________________________
QA Management
Date
Printed Name
______________________
_____________
________________________
Note: QA Management approval not required in the EU if this document is completed or approved by a
Qualified Person.
Address:
Type of Company:
Intended Use:
Category as per
SOP xyz
Points to consider
Background information
Reason for (re-)qualification
Description / Details / Information
Supplier History / Changes
Current status of supplier / service provider Satisfactory (approved for use)
Restricted
Unsatisfactory (not approved for use)
Not rated yet
Approved by sister division
Assessment / Monitoring activities
as per Sop xyz:
 Questionnaire
 Audit
 Audit sister division / third party
 Quality history
 Certificates
 others
Audit Report (date of approval)
Audit Letter (date of mailing)
Response to observations (receipt,
comments))
Rating of supplier as per SOP xyz
(with limitations if applicable)
Next evaluation/ monitoring
Date and signature of person who
performed assessment / monitoring
Approval QA Management
(QP for Europe)
_______________________________________
(Name and function)
_______________________________________
(Name and function)
Item
1
Company profile (including a description of the type of business)
(Please describe your company)
1.1
Address:
Year company was established:
Internet address:
1.2
Does your company have other sites?
1.3
Details of company ownership:
1.4
Are you part of a corporation?
1.5
Details on size of company
(applicable site)
No ( )
Yes( )
(please provide address)
No ( )
Yes( )
Number of employees:
Number of employees involved in Quality Management:
Size of company premises in square meters:
1.6
Details on range of services provided
1.7
Please attach an organization chart to this questionnaire.
2
Quality
2.1
Is your company certified according to any guidelines? Which?
>
>
>
>
DIN EN ISO 9001
SCC/SGU
DIN EN ISO 14001
OHSAS 18001
No
No
No
No
(
(
(
(
)
)
)
)
Yes
Yes
Yes
Yes
(
(
(
(
)
)
)
)
(please
(please
(please
(please
attach
attach
attach
attach
certificate)
certificate)
certificate)
certificate)
Are any other quality assurance measures installed? If yes, which?
2.2
Is your company certified according to other criteria (e.g. GxP, GSP, GDP,etc.)?
No ( ) Yes
( )
(please attach certificate)
2.3
Do you perform audits on your own company?
No
( )
Yes
( )
2.4
Do you employ qualified subcontractors (e.g.
housekeeping, pest control, transport, storage?)
No
( )
Yes
( )
If yes, do these companies have the same or similar
qualifications as your company does?
No
( )
Yes
( )
3
Have you worked for a company belonging to the xyz corporation before?
Or are you currently already working under contract in our company?
No
( )
If yes, which organisation? When?
3
Please supply the following details:
Name and telephone number of person responsible for Quality Management
Comments
This questionnaire was completed by:
Name/signature:
Function:
Date:
Yes
( )
Please return to:
Quality Assurance Department
Number of inquiry:
Company profile
Company name:
Address:
Telephone
number:
Fax number:
Contact person:
Please enclose company brochure
and organizational chart
Ownership
Contact persons for:
Private society
One owner
Mixed
Sales department
Quality
department
Representative
State company
Technical
department
Job type
Production
Services
Distribution
Row materials/APIs
Montage/Installation
Other (Please name)
Number of employees
Total :
Finance and
administration
(
)
Do you have more than one
facility/site?
Distribution
(
)
Yes
Production
Development
Engineering
(
(
(
)
)
)
(
)
No
(
)
Management responsibilities
Do you have company mission?
(Please enclose)
Yes
(
)
No
( )
Do you have written environment protection policy?
(Please enclose)
Do you have or you are in process of establishing the management
system for environment protection?
If the answer is yes, are you in compliance with ISO14001 or EcoManagement ?
Do you have regular meetings consecrate to quality analyses?
Do you have official quality policy?
(Please enclose)
Do you have Quality Manuel (QM)?
(Please enclose table of contents)
Does you company have ISO accreditation?
GMP or PCP (Pharmaceutical Code of Practice) accreditation?
(Please enclose copy of Certificates)
Do you have GMP Certificate issued by MHRA?
Do you have GMP Certificate issued by FDA?
Do you have Health and Safety Protection of employees policy?
Yes
(
)
No
( )
Yes
(
)
No
( )
Yes
Yes
Yes
(
(
(
)
)
)
No
No
No
( )
( )
( )
Yes
(
)
No
( )
Yes
Yes
(
(
)
)
No
No
( )
( )
Yes
Yes
Yes
(
(
(
)
)
)
No
No
No
( )
( )
( )
Yes
Yes
Yes
Yes
Yes
(
(
(
(
(
)
)
)
)
)
No
No
No
No
No
(
(
(
(
(
)
)
)
)
)
Yes
(
)
No
(
)
Yes
Yes
Yes
(
(
(
)
)
)
No
No
No
(
(
(
)
)
)
Do you supply other pharmaceutical companies?
Yes
(
)
No
(
)
Do you have:
Yes
Yes
Yes
(
(
(
)
)
)
(
(
(
)
)
)
Yes
Yes
(
(
)
)
No
No
(
(
)
)
Yes
(
)
No
(
)

Quality Assurance
Do you have:
Product specification?
Process specification?
Internal control procedure?
Meetings devoted to quality improvement?
Control and testing plans?
Formalized system of compliance with
customers?
Is the system batch approval and batch release independent from
production process?
Have your procedures been checked by external inspection?
Has your computer system been harmonized with GAMP 4?

Production
Production procedures?
Inter-process control?
Identification and Traceability of product?
(please enclose procedure for batch marking)
Procedure for deviations?
Pest control program?
Do you use statistical analyses in production
monitoring?
No
No
No

Purchasing
Do you have:
Row materials/excipients/API specification?
Purchasing records?
Packaging material specifications?
Qualified suppliers?
Supplier evaluation system?
Do you have regular inspection for your suppliers?
Do you work according the official supply contract?

Yes
Yes
Yes
Yes
Yes
Yes
Yes
(
(
(
(
(
(
(
)
)
)
)
)
)
)
No
No
No
No
No
No
No
(
(
(
(
(
(
(
)
)
)
)
)
)
)
Final product
Do you have:
Storage and handling procedures?
Yes
(
)
Procedure for withdrawal from the market?
Yes
(
)
Your own distribution?
Yes
(
Quarantine area?
Yes
Dispatch control?
No
(
)
No
(
)
)
No
(
)
(
)
No
(
)
Yes
(
)
No
(
)
Internal Controls of Goods?
Yes
(
)
No
(
)
Do you have CoA and CoC?
Yes
(
)
No
(
)
Information
Please put the details below about the person responsible for filling this questionnaire:
Name:
Title:
In behalf of:
(name and company
stamp)
General Information
Overview
This questionnaire is provided to prospective or current clinical trial (study)
distribution /depot sites, to be completed as a self-assessment of their
warehousing and distribution capabilities, quality systems and applicable
processes. It is not to be used for organizations that repackage or transfer
material from one container system to another.
Name of Company:
Address:
City:
State/Province:
Post / Zip Code:
Website address:
Phone Number:
Fax Number:
Distributor Facility Information:
Number of Facility Personnel (total): ________
Note: Please attach a copy of your organizational structure.
Country:
Are all distribution operations carried out at this location only? Yes
No
If no, what processes and services are not carried out at this location?
List the primary type of activities performed with clinical products (i.e. distribution, packaging, overlabeling, returned goods, etc.)
Has this location performed clinical study distribution activities before? Yes
No
If yes, mark the type:
Double-Blind
Single-Blind
Open-Label
Other (specify type) ___________________________________________________________
Do you utilize other facilities or distribution centers other than your own to distribute clinical
supplies? Yes
No
If yes, provide the name and location of facilities used in addition to your
own.
Would your site be receptive to an on-site evaluation by a representative of Pharmaxyz Laboratories?
Yes
No
If no, please explain: _________________________________________________
Would a confidentiality agreement be required for the evaluation? Yes
No
Has your company been inspected by U.S. FDA, or another countries government / organization?
Yes
No
If yes, provide the name of the regulatory agency, inspection dates, and results:
Does the site maintain GMP certification, or is it registered with the U.S. FDA? Yes
No
If yes, attach a copy of the GMP certificate and / or provide the FDA establishment registration number:
Is this facility inspected by any other local, State, Federal/Country regulatory agencies? Yes
If yes, please list them:
No
Is this facility ISO 9000 certified? Yes
No
If yes, who is the Registrar? _____________________
If no, is there a plan to certify this facility? Yes
No
Is the facility a Controlled Drug site (e.g., authorized to receive, store and distribute controlled drug
substances such as Schedules I, II, III, IV, and V materials)? Yes
No
If yes, to what agency / organization(s) is the facility registered? _______________________________
Are there drug accountability (inventory) procedures? Yes
No
Does the site compare inventory records with actual receipts, shipments, returns, etc? Yes
Does the site record what is sent out? Yes
No
No
Are unused clinical products stored separately from returned clinical products? Yes
No
Are there documented controls and established responsibilities in place for the destruction of unused
and/or returned clinical supplies? Yes
No
Is there documentation that clinical products returned to your facility were returned to the sponsor or
disposed of according to the sponsor’s instructions? Yes
No
Are there controls / instructions in place to ensure that the shipping of clinical supplies are conducted
according to instructions given by or on behalf of the sponsor? Yes
No
If the site is notified by any party along the supply chain of a complaint or inquiry, are there documented
procedures in place to receive and record the conclusions of any investigation carried out in relation to a
complaint or inquiry which could arise from the quality of the product? Yes
No
Does the site maintain adequate records that include the name of the investigator to whom the study
drug was shipped? Yes
No
Does the site have the capability to show where clinical supplies were sent but not to reveal the name of
the investigator to whom the clinical supplies were sent? Yes
No
Attestation of Review and Approval
Where possible, the Warehouse Manager and a Quality or Regulatory Affairs representative must sign
this form. Provide an explanation if the signature if from any other function.
_____________________________________
Signature
__________________________
Title
______________
Date
_____________________________________
Printed Name
_____________________________________ ___________________________ _______________
Signature
Title
Date
_____________________________________
Printed Name