CHAPTER 13

QUALITY ASSURANCE

REF

WHO 32

Yes

No

1

Section 1.1

Is there in the company a quality assurance system?

2

Section 1.3

Are there in the company the competent personnel who coordinate the quality assurance system?

3

Sections

1.1 and 1.3

Is the quality policy spread at all levels within the company?

3.1

Are there written procedures for that spread?

4

Section 1.2(I)

Is there SOP of self-inspection and/or audit of quality through which the effectiveness and applicability of the system of the quality assurance is evaluated regularly?

5

Section

14.9

If the documentation is carried out through electronic data processing methods does the company kept a reserve copy of the documentation?

5.1

Section 14.9

Is the admission of new data or modifying of the existing data in the computer system done only by the people authorized?

5.2

Section

14.9

Is a record of the data modifications and/or elimination kept?

5.3

Section 14.9

Are passwords or other means to restrict the access to the system established?

5.4

Section 14.9

Are the records of lots electronically filed protected?

5.5

Is there a program of control of the SOPs?

6

Is the approval and monitoring of the activities of validation a responsibility of quality assurance?

7

Sections

1.2 (a);(b)

and (f)

Does Quality assurance have authority for the review of the records of production and analytical protocols in order to confirm if every lot of product is made and controlled correctly in accordance with the defined procedures?

REF

WHO 32

QUALITY ASSURANCE

Yes

No

8

Section 14.8

Does Quality assurance guarantee that the documentation of every lot produced is filed?

8.1

Sections 1.2.(g) and 3.2(g)

Is there a SOP for release products to the market?

9

Section

16.15

If in the review of the production records are detected bypasses of the established procedures, is quality assurance responsible for ensuring a complete investigation of the bypasses and that the final conclusions are justified?

10

Section

16.15

If a lot it does not meet specifications, does the investigation is extended to other lots of the same product and of other products that could have had some relation with the defect or the discrepancy?

11

Section 1.2(e)

Is Quality assurance responsible for verify that the SOP’sof all areas (production, quality control, engineering, maintenance, etc.) are consistent with the quality system?

12

Section 14.4

Does the company kept originals of all procedures and records of distribution of the authorized copies?

13

Section 14.5

Are the procedures reviewed within their validity period?

14

Section 14.5

If a procedure is modified, is there a system by which the accidental use of a previous version is prevented?

15

Sections 10.11 and 10.12

Does Quality assurance verify the fulfillment of the staff training plans?

REF

WHO 32

STABILITY

Yes

No

20

Section 16.19

Does the program of quality assurance include stability studies of products?

21

Section 16.19

Is there a written program for stability study of the products?

22

Section 16.19

Does stability study program include:

22.1

Section 16.19

A complete description of the product studied?

REF

WHO 32

STABILITY

Yes

No

22.2

Section 16.19

The controlled parameters and validated analytical methods that demonstrate the stability of the product in concordance with the established specifications?

22.3

Section 16.19

A sufficient number of lots (no less than three)?

22.4

Section 16.19

Timetable of the analytical tests to carry out for every product?

22.5

Section 16.19

Special storage conditions?

22.6

Section 16.19

Sufficient quantities of samples in order to fulfill with the program?

22.7

Section 16.19

A summary and obtained data including the evaluations and study conclusions?

22.8

Section 16.19

A system of monitoring of the marketed products that makes it possible to confirm that, if the conditions of storage are met, the product maintains its quality during its validity period?

22.9

Section 16.19

Is the program fulfilled?

REF

WHO 32

CALIBRATION

Yes

No

23

Is there a program for calibration for the measuring instruments?

24

Is there indicated in the same which operations are carried out internally and which by contracted services?

25

Is the frequency of calibration indicated in the same?

26

Is the program fulfilled?

27

Are the calibration records filed? Are they shown?

27.1

In case of calibrations and/or internal verifications the laboratory does it have standards?

28

Are the corresponding certificates exhibited?

REF

WHO 32

QUALITY AUDITS/ SELF-INSPECTIONS

Yes

No

29

Section 9.1

Are quality self-inspections and/or audits carried out?

30

Section 1.2(i)

Is Quality assurance responsible for the coordination of quality self-inspections and/or audits?

31

Section 9.1

Are the self-inspections/audits carried out with a pre-established plan?

32

Section 9.5.(c)

Are the necessary corrective measures recommended?

33

Section 9.1

Are quality self-inspections and/or audits carried out also in other situations, for example in the event that a product is removed of the market or rejected repeatedly?

34

Section 9.3

Is there a team in charge of quality self-inspections/audits?

35

Section 9.2

Do the written instructions of quality self-inspection/ audits include, at least, the following points:

35.1

Section 9.2(a)

Personnel?

35.2

Section 9.2 (b)

Premises and services?

35.3

Section 9.2(c)

Maintenance of buildings and equipment?

35.4

Section 9.2(d)

Storage of materials and finished products?

35.5

Section 9.2(e)

Equipment?

35.6

Section 9.2(f)

Production and controls during the process?

35.7

Section 9.2(g)

Quality control?

35.8

Section 9.2(h)

Documentation?

35.9

Section 9.2I

Sanitation and hygiene?

35.10

Section 9.2(j)

Validation and confirmation programs?

35.11

Section 9.2(k)

Calibration of instruments and measurement systems?

35.12

Section 9.21

Procedures of withdrawal of products of the market?

35.13

Section 9.2(m)

Management of claims?

REF

WHO 32

QUALITY AUDITS/ SELF-INSPECTIONS

Yes

No

35.14

Section 9.2(n)

Control of labels?

35.15

Section 9.2(o)

Results of previous self-inspections and adopted corrective measures?

36

Section 9.5

The report issued once finished the self-inspection contains:

36.1

Section 9.5(a)

Results of the self-inspection?

36.2

Section 9.5(b)

Evaluation and conclusions?

36.3

Section 9.5(c)

Corrective measures recommended?

37

Is the monitoring of the corrective measures carried out and register?

REF

WHO 32

AUDIT TO SUPPLIERS

Yes

No

38

Are the suppliers of good, production and quality control third parties evaluated (if is necessary audited) and approved by quality assurance?

39

Is there a record of approved suppliers available for the areas that require it?

40

Is there a program for evaluation and audits to suppliers?

41

Is it fulfilled?

42

Are records of these evaluations and audits kept?

43

Is an assessment of the outcomes made?

44

Are measures adopted when the results are not favorable?

REF

WHO 32

CLAIMS

Yes

No

45

Sections

6,2 and 6.4

Is Quality assurance responsible for coordinating the reception and the monitoring of the received claims?

46

Section 6.2

Is there a responsible person assigned?

47

Sections

6.1 and 6.3

Are written procedures for the reception and investigation of the claims?

48

Section 6.4

Is record of the claims kept?

49

Section 6.5

If necessary, is analytical control made?

50

Section 6.6

Do the decisions made concerning the complaints remain documented, in the lot records, by quality bypasses of the product?

51

Sections

6.2 and 6.7

Are corrective measures adopted?