REF
WHO 32 
QUALITY CONTROL

YES 
NO

19.1
Sections3,2(b);
3.2(h); 16.2
and 16.7 
a) Raw materials?



19.2
Sections3,2(b);
3.2(h); 16.2
and 16.7 
b) Packaging materials?



19.3
Sections 3,2b; 3.2(h); 16.2 and
16.7 
c) Intermediate product?



19.4
Sections3,2(b);
3.2(h); 16.2
and 16.7 
d) Finished product?



20
Section 16.3

Are the sampling methods for tests representative of
the totality of the lot or batch?



20.1
Section 16.3 
Are these procedures fulfilled?



21
Sections
13.11 y 16.9. 
Are the sampled containers correctly analyzed and
identified?



22
Sections 13.11;
16.9 y 16.7 
Does the number of sampled containers agree with the
sampling standard?



23
Sections
14.37(a); 16.3 and 16.8 
Are all incoming packaging materials, without
exception, sampled by Quality Control in accordance
with the established standard?



24 
Is there a SOP for the approval and rejection of the
materials?



25
Section 16.5 
Are there the elements necessary for the sampling?



25.1
Section 16.5 
Are the sampling elements conserved in good
condition?



25.2
Section 16.6 
Are the sampling elements duly stored and labeled?



25.3
Section 16.6 
Is there a written procedure for the cleaning, use,
and conservation of the sampling elements? 


REF
WHO 32 
QUALITY CONTROL

YES 
NO

26
Section 3.2

Are the analytical methods utilized authorized by
the one responsible of Quality Control?



27 
Is there a program for validation for the methods
that are not published in pharmacopoeias
internationally recognized?



27.1 
Is there a record of compliance with that validation
program?



28
Sections 3.1;3.2;
14.13 and 14.18 
Are there specifications for:



28.1
Section 16.8 
Raw materials?



28.2
Section 16.8 
Packaging materials?



28.3
Section3.2 
Intermediate product?



28.4
Section 16.13

Finished product?



29
Section 13.19

Are there SOPs that indicate the frequency of
reanalysis and the validity of the carried out
tests?



291 
Are these procedures fulfilled? 


30
Section 3.2(h)

Are samples of retention of the active raw materials
and finished products, in enough quantity to carry
out all the tests by duplicate, kept in accordance
to a SOP?



31
Section 16.16

Are the retention samples of finished products kept
until a year after the expiry date of the product?



31.1
Section 16.16

Are the samples of retention of raw materials kept
until a year after the expiry date of the last lot
of product prepared with them?



32
Section13.34 
Are there standards and reference materials?



32.1
Section 14.12 
Is a record of the primary standards kept?



REF
WHO 32 
QUALITY CONTROL

YES 
NO

32.2
Section 14.12 
Is a record of the secondary standards kept?



32.3
Section 14.12 
Is a record of the reference materials kept?



33
Section13.36

Does the company have primary standards, coded by
Pharmacopoeias or internationally recognized
agencies, for each active ingredient?



33.1
Section 14.12 
Are the primary standards from the current lot?



34
Section 14.12

Do all the secondary standards and reference
materials have current analytical certificate?



35
Section 13.36

Are there SOPs for the preparation, use and
conservation of standards and reference materials?



35.1 
Are those procedures fulfilled?



35.2
Section 13.36 
Are the records shown?



36
Section 13.36

Are tests of characterization and purity carried out
to the samples to be utilized as reference
substances of noncoded active ingredient?



37 
Does the company have impurities and related
substances standards, officials or nonofficials,
especially for those considered toxic?



38
Section 3.2

Does the company have all the reagents needed for
carried out the routine physicochemical assays?



38.1
Section 3.2 
Are the reagents correctly labeled?



39
Section 13.32 
Are volumetric solutions used?



39.1
Section 13.32

Is there a standard operating procedure for the
preparation, use, and,conservation of volumetric
solutions?



40
Section 13.32 
Do every container of analytical solution have a
label where there is indicated:



REF
WHO 32 
QUALITY CONTROL 
YES 
NO

40.1
Section 13.32 
Name of the solution?



40.2
Section 13.32 
Concentration  standardization factor?



40.3
Section 13.32 
Preparation date?



40.4
Section 13.32 
Responsible?



40.5
Section 13.32

Retest date?



40.6
Section 13.32 
Expiry date?



40.7
Section13.32 
Storage conditions?



40.8
Section 13.32 
Safety category? 


40.9
Section 13.32 
Reference to the SOP?



41
Section 13.32

Are the unstable reagents labeled with reception
date, opening date and expiry date? 


42
Sections 3.2.3 and 14.9 
Do the analysts have a logbook in which are recorded
the laboratory results? 


43 
Are the calculations dated and signed by the
analyst?



44
Section 14.43

If there are observed modifications of data, is the
amendment carried out dated and signed?
Does the amendment make possible to visualize the
original datum?



45 
In the records of the analyses, it is indicated:



45.1 
Name of the analyzed material?



45.2 
Lot number?



45.3 
Analysis number?



45.4 
Obtained results?



45.5 
Date? 


REF
WHO 32 
QUALITY CONTROL

YES 
NO

45.6 
Utilized methods and specifications?



45.7 
Signs/ initials of the people who carried out the
test?



45.8 
Sign/initials of the person that verified the tests
and calculations?



45.9 
In case of having computerized systems for the
acquisition of data, do they make it possible to be
confirmed?



46 
Does Quality control check if each manufactured lot
meets the established specifications?



46.1 
Are there records?



46.2 
Are the causes of the out of specifications results
investigated? 


46.3 
Are there records of this investigation?



46.4 
Are there records of the actions taken in those
cases?



47 
Does the records of the tests contain at least the
following information:



47.1 
Sample identification?



47.2 
Date?



47.3 
Name of the analyst?



47.4 
Identification of the reference standard?



47.5 
Parameters and conditions that correspond?



48
Section 17.90 
Are tests of bacterial endotoxins carried out in raw
materials and goods declared as pyrogenfree by the
supplier, to be used in the injection manufacture?


