B.

1.

2.

3.

4.

5.

6.

7.

8.

9.
10.

11.

B.
1.

Quality System (NaCl)

Is your company ISO 9000
registered? If yes, by what
agency or registrar granting
certification, to what level, and
when is the expiration date?
Please provide a copy of ISO
certificate as attachment of
this Questionnaire
If no, are you currently
pursuing ISO 9000
registration?
If you are currently pursuing
your ISO 9000 registration,
when is an audit scheduled?
If multiple facilities/operations
exist in your company, are
these also ISO certified?
Do you have a supplier
qualification/rating system in
place? If yes, please describe
If not, how do you approve
your suppliers and manage
their quality issues?
How are your management
kept informed of quality
issues?
Do you have a Quality
Improvement Plan?
Do you have a procedure to
periodically
calibrate
measurement/
test
equipment?
Do you provide the training
associated with quality system
to the employees? If yes, how?
Quality System (Propiparaben)
Is the suppliers system of the Quality
Assurance adequately described in
approved written

2.

3.

4.

5.
6.

7.

8.

10.
11.

B.
1.

2.

procedures/instructions/policies?
Are procedures/instructions/policies
maintained current and made
available to all concerned personnel?
Has the responsibility for Quality
Assurance/Inspection been formally
established? (Organization Chart)?
Does the Quality Assurance/Inspection
Department have the freedom to
satisfactory perform the quality
functions and meet customer
requirements?
Is a periodic review of the quality
program performed by management?
Does the organization ensure control
over any outsourced process which
affects product conformity?
Does the Quality Assurance/Inspection
Department prepare quality plans to
identify and implement quality
requirements?
Does the Quality Assurance/Inspection
review manufacturing processes,
contract reviews, packaging, and
inspection & test
instructions to assure customer
requirements?
Is there a documented quality policy?
Is the responsibility and authority of the
quality parties defined?

Quality System (Medroxyprogesterone acetat)

Is the quality units authority
and responsibility clearly
defined in writing?
Does the quality unit have
independent authority to
approve and reject procedures,

3.

4.

5.

6.

7.
8.
9.
10.

11.

specifications, and process

changes
Does the quality unit have the
authority to ensure that
manufacturing and testing
records are reviewed before
batches are released for sale?
Please describe the program to
qualify suppliers of raw
materials, components, and
services that might affect
quality, and verify that they
have the capability to
consistently meet agreed upon
requirements.
Does the supplier program
include periodic audits (or other
verification techniques) of
suppliers?
Please describe your cGMP
employee training program. Is
the program in writing? How
often is GMP training conducted?
Is GMP training conducted by
qualified individuals?
Is GMP training conducted for
new and temporary employees?
Are training and qualifications
documented for each employee?
Please explain how employee
proficiency is monitored and
measured?
Who within your organization
will notify our firm of such an
inspection that impacts raw
materials, processes, and active
ingredients?