PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 PURPOSE
To lay down the procedure for Sampling and Inspection of drug products by attributes in terms of
Acceptance Quality Level (AQL) before release.

2.0 SCOPE
2.1 This SOP is applicable to sampling and inspection of all bulk finish drug product before release for packing
and pack finish drug product before release for distribution by attributes in terms of AQL at ……………..

3.0 REFERENCE(S) & ATTACHMENTS

3.1 References
3.1.1 SOP No.: “Destruction of materials or Products”
3.1.2 SOP No.: “Incident Reporting and Investigation”
3.1.3 SOP No.: “Status Labeling”
3.1.4 SOP No.: “Quality Risk Management”
3.1.5 SOP No.: “CAPA (Corrective and Preventive Action) handling procedure”

3.2 Attachments
3.2.1 Attachment-I : AQL sampling and inspection plan for bulk finish drug products (for
first AQL inspection).
3.2.2 Attachment-II : AQL sampling and inspection plan for bulk finish drug products (for
repeat AQL inspection)
3.2.3 Attachment-III : AQL sampling and inspection plan for pack finish drug products (for
first AQL inspection)
3.2.4 Attachment-IV : AQL sampling and inspection plan for pack finish drug products (for
repeat AQL inspection)
3.2.5 Attachment-V : Bulk finish drug product AQL inspection report
3.2.6 Attachment-VI : Pack finish drug product AQL inspection report
3.2.7 Attachment-VII : Defect analysis of bulk finished products
3.2.8 Attachment-VIII : Defect analysis of pack finished products
3.2.9 Attachment-IX : Flow chart of AQL inspection
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.0 DEFINITION & ABBREVIATION(S)

4.1 Definitions
4.1.1 Inspection by attributes: Inspection where by either the unit of product is classified simply as defective or
no-defective, or the number of defects in the unit of product is counted, with respect to a given requirement
or set of requirements.
4.1.2 Acceptable Quality Level (AQL): The Acceptance Quality Level (AQL) is defined as the maximum
percent defective (or the maximum number of defects per hundred units) that, for purpose of sampling
inspection, can be considered satisfactory as a process average.
4.1.3 Inspection Levels: The standard provides for three general inspection levels (i.e. Level I-Reduced
Inspection, Level II- Normal Inspection, Level III- Tightened Inspection) and four special inspection levels.
These levels permit the user to balance the cost of inspection against the amount of protection required. This
guideline designed based on Normal Inspection level.
4.1.4 Normal Inspection: Normal inspection is that which is used where there is no evidence that the quality of
product being submitted is better or poorer than the specified quality level.
4.1.5 Sampling Plan: A lot sampling plan is a statement of the sample size or sizes to be used and the associated
acceptance and rejection numbers.
4.1.6 Representative Sampling: When appropriate, the number of units in the sample shall be selected in
proportion to the size of sub-lots or sub-batches, or parts or the lot or batch, identified by some rationale
criterion. When representative sampling is used, the units from each part of the lot or batch shall be selected
at random.
4.1.7 Critical Defects: A critical defect is on that judgment and experience indicate is likely to result in hazardous
or unsafe conditions for individuals using, maintaining, or depending upon the products.
4.1.8 Major Defects: A major defect is one, other than critical, that is likely to result in failure, or to reduce
materially the usability of the unit of product for its intended purpose.
4.1.9 Minor Defects: A minor defect is one that is not likely to reduce materially the usability of the unit of
product for its indented purpose, or is a departure from established standards having little bearing on the
effective use or operation of the unit of product.

4.2 Abbreviations
4.2.1 AQL: Acceptance quality level
4.2.2 SOP: Standard operating procedure
4.2.3 etc.: Etcetera
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.2.4 i.e.: That is

4.2.5 e.g.: Example gratia
4.2.6 BMR: Batch manufacturing record
4.2.7 BPR: Batch packing record
4.2.8 QA: Quality Assurance
4.2.9 %: Percent
4.2.10 No.: Number
4.2.11 RH: Relative humidity

5.0 RESPONSIBILITY:
5.1 Production Personnel:
5.1.1 To perform on-line sampling.
5.1.2 To intimate the Quality Assurance department for the inspection of batch samples.
5.1.3 To take appropriate action based upon the outcome of AQL inspection.
5.2 QA Personnel
5.2.1 To prepare and implement the SOP as per this guideline.
5.2.2 To do the AQL sampling and inspection as per SOP.
5.2.3 To take appropriate action based upon the outcome of AQL inspection.
5.3 Quality Assurance Head:
5.3.1 To ensure that the AQL sampling inspection procedure is followed as per SOP.
5.3.2 To review and approve the investigation reports in case if batch does not meet AQL.
5.3.3 To ensure implementation the system.
5.4 Plant Head:
5.4.1 To ensure implementation of the defined procedure.

6.0 Distribution:
I. Quality Assurance
II. Production

7.0 PROCEDURE:
7.1 Sampling and inspection of bulk finish drug products:
Note: AQL sampling shall be performed at stages depends upon the mode of operation. i.e. either during on-
line manufacturing or after the completion of visual inspection by Production department.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.1.1 After completion of the manufacturing &/or inspection of drug product (i.e. after Compression or Coating of
Tablets, after Capsule filling, production department shall intimate to the Quality Assurance department for
AQL sampling and inspection of the batch.
7.1.2 QA Inspector shall perform the sampling & inspection in the same cubicle/area (i.e. Compression/ Filling/
Coating/ inspection room etc.). Before start of AQL sampling & inspection, QA Inspector shall check &
ensure that environmental conditions are within the limit as mentioned in BMR and record the same in the
AQL inspection report (Attachment-V).
7.1.3 As per the batch size of the respective drug product, the sample size code letter and sample size shall be
identified by QA from the AQL sampling inspection plan provided as Attachment-I.
e.g. If batch size of the product is 100000 units, then for first AQL inspection, sample size code letter shall
be N and first sample size shall be 315 units.
7.1.4 The number of samples first inspected shall be equal to the first sample size given in the sampling plan, i.e.
Attachment-I.
7.1.5 After collecting the sample, same shall be inspected for Critical, Major and Minor defects. Refer
Attachment-VII for Critical, Major and Minor defects of various bulk finish drug products.
7.1.6 Compare the results of the first sample size inspection against the acceptance criteria as provided in
Attachment-I.
7.1.7 If the number of nonconforming items found in the first sample is equal to or less than the first acceptance
number, the lot/batch shall be considered as acceptable.
e.g. For the batch size of 100000 units, 315 units (first sample size) shall be inspected for defects. If the
number of nonconforming items found equal to or less than the first acceptance number, i.e. 0 for Critical &
Major defects respectively & 1 for minor defects, the lot/batch shall be considered as acceptable.
7.1.8 If the number of nonconforming items found in the first sample is equal to or greater than the first rejection
number, then lot shall be considered as not acceptable. In such case follow the procedure defined in the step
no. 7.2.
e.g. In above example of step no. 7.1.3, if the number of nonconforming items found in the first sample (i.e.
315 units) is equal to or greater than the first rejection number, i.e. 1 for Critical defects & 3 for Major &
Minor defects respectively, then lot shall be considered as not acceptable.
7.1.9 If the number of nonconforming items found in the first sample is between the first acceptance and rejection
number, a second sample of the size given in the plan shall be inspected.
e.g. In above example of step no. 7.1.3, if the number of nonconforming items found in the first sample is
between the first acceptance and rejection number, i.e. more than 0 for Critical defects, between 0 to 3 for
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Major defects and between 1 to 3 for Minor defects, then a second sample of the size given in the plan (i.e.
315 units) shall be inspected.
7.1.10 The number of nonconforming items found in the first and second samples shall be accumulated. If the
cumulative number of nonconforming items is equal to or less than the second acceptance number, the lot
shall be considered acceptable.
e.g. In above example of step no. 7.1.3, if the cumulative number of non-conforming items is equal to or less
than the second acceptance number, i.e. 0 for Critical, 3 for Major and 4 for Minor defects respectively, then
the lot shall be considered acceptable.
7.1.11 If the cumulative number of nonconforming items is equal to or greater than the second rejection number, the
lot shall be considered as not acceptable. In such case follow the procedure defined in the step no. 7.2.
e.g. In above example of step no. 7.1.3, if the cumulative number of nonconforming items is equal to or
greater than the second rejection number, i.e. 1 for Critical, 4 for Major and 5 for Minor defects respectively,
the lot shall be considered as not acceptable.
7.1.12 Record all the observations in the Attachment-V or in the provision provided in the respective BMR.
7.1.13 If the results observed within the acceptance criteria, mention the remark as “Satisfactory” with sign and date
of inspector.
7.1.14 Attach the copy of filled “Bulk Finish Drug Product Inspection Report” (Attachment-V) with the respective
Batch Manufacturing Record.
7.1.15 After completion of the inspection, destroy the defected samples as per SOP titled as “Destruction of
materials or Products” and record the quantity in respective batch manufacturing record. Handover the
inspected good samples to concern production supervisor, who shall add these samples in the last container
of bulk product.

7.2 Handling of AQL failure of bulk finish drug products:

7.2.1 If the results are not as per acceptance criteria, mention the remark as “Not Satisfactory, 100 % re-inspection
of the batch is to be carried out” along with sign and date of inspector in the Attachment-V or in the BMR, as
applicable.
7.2.2 Responsible Production Supervisor shall conduct the re-inspection of the batch along with defect analysis
(i.e. no. of tablets of each type of defect) and record the activities in the respective batch manufacturing
record. Sampling of inspected bulk finish drug product shall be done by Production supervisor as per step no.
7.1.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.2.3 After the completion of re-inspection of the batch, Production Supervisor shall intimate to the QA inspector
for repeat AQL sampling and inspection.
7.2.4 QA inspector shall perform the repeat AQL sampling and inspection as per below procedure.
7.2.4.1 As per the batch size of the respective drug product, the sample size code letter and sample size shall be
identified by QA inspector from the AQL sampling inspection plan provided as Attachment-II.
7.2.4.2 The number of samples first inspected shall be equal to the first sample size given in the sampling plan, i.e.
Attachment-II.
7.2.4.3 After collecting the sample, same shall be inspected for Critical, Major and Minor defects. Refer attachment-
VII for Critical, Major and Minor defects of various bulk finish drug products.
7.2.4.4 Compare the results of the repeat AQL inspection against the acceptance criteria as provided in Attachment-
II.
7.2.4.5 If the number of nonconforming items found in the first sample is equal to or less than the first acceptance
number, the lot/batch shall be considered as acceptable.
7.2.4.6 If the number of nonconforming items found in the first sample is equal to or greater than the first rejection
number, then lot shall be considered as not acceptable. Mention the remark as “Not Satisfactory” in the
Attachment-V or in the BMR (as applicable) and intimate the same to concern Department Head, QA Head
and Plant Head. Concern Department Head shall raise the deviation & carry out investigation as per SOP
titled as “Incident Reporting and Investigation”. Root cause analysis for the failure shall be carried out as per
SOP titled “Quality Risk Management” to find out the root cause and risk assessment shall be done
simultaneously. CAPA shall be taken as per SOP titled “CAPA (Corrective and Preventive Action) handling
procedure” based on the identified root cause or probable root cause.
7.2.4.7 If the number of nonconforming items found in the first sample is between the first acceptance and rejection
number, a second sample of the size given in the plan shall be inspected.
7.2.4.8 The number of nonconforming items found in the first and second samples shall be accumulated. If the
cumulative number of nonconforming items is equal to or less than the second acceptance number, the lot
shall be considered acceptable.
7.2.4.9 If the cumulative number of nonconforming items is equal to or greater than the second rejection number, the
lot shall be considered as not acceptable. Mention the remark as “Not Satisfactory” in the Attachment-V or
in the BMR (as applicable) and intimate the same to concern Department Head, QA Head and Plant Head.
Decision on further course of action or disposition of batch shall be taken by QA Head in consultation with
Plant Head and CQA Head.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.2.5 The samples along with the batch shall be stored in appropriate condition and with ‘Under Hold’ label as per
Attachment- XII of SOP titled as “Status Labeling” by QA department until the completion of investigation
and final decision on the lot.
7.2.6 After completion of the investigation, the defected sample shall be destroyed as per SOP titled as
“Destruction of Materials or Products”.
7.2.7 If the decision is taken for destruction of the lot, it shall be destroyed as per SOP titled as “Destruction of
Materials or Products”.

7.3 Sampling and inspection of pack finish drug products:

7.3.1 During Packing operation, packing department shall intimate to the Quality Assurance department for AQL
sampling and inspection of the batch.
7.3.2 As per the batch size of the respective drug product, the sample size code letter and sample size shall be
identified from the AQL sampling inspection plan provided in Attachment-III.
Note: Batch size of the pack finish drug product batch should be considered in terms of packed units as per
respective pack style.
e.g.:
7.3.2.1 If the batch size of the Tablet drug product in manufacturing stage is 50000 Tablets and same is being
packed in the 100 count bottle pack, then batch size at packing stage shall be 500 units (i.e. 500 bottles of
100 tablets each). In this case batch size as 500 units shall be considered for deriving sample size for AQL
inspection. As per Attachment-III & IV, first sample size for this lot size shall be 32 units.
7.3.2.2 In above example, if batch after manufacturing is being packed in more than one pack style (e.g. 100 count
bottle pack and 10 count blister pack), then batch size of individual pack style shall be considered based
upon the quantity of bulk tablets assigned for each pack. For example, if 20000 tablets assigned for 100
count bottle pack and 30000 tablets assigned for 10 count blister pack, then batch size of bottle pack shall be
200 units and that of blister pack shall be 3000 units. Sample size for AQL inspection of individual pack
style lot shall be derived based upon batch size of individual lot. In this case first sample size for AQL
inspection shall be 20 units for bottle pack and 80 units for blister pack.
7.3.3 After getting the sample size, QA shall collect the representative samples uniformly from the pack line.
Note:
7.3.3.1 If total number of boxes/shippers of pack finish product is 10 or less than 10, then sample shall be collected
from all the boxes/shippers.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.3.3.2 If total number of boxes/shippers of pack finish product are more than 10, then calculate the value of √n + 1
(square root of n + 1).
Where “n” is the total number of pack finish product boxes/shippers.
If value of √n + 1 is less than 10, then sample shall be collected from at least 10 boxes/shippers.
If value of √n + 1 is more than 10, then sample shall be collected from √n + 1 boxes/ shippers.
Example: If total number of sample is to be collected is 200 units and total number of boxes/shippers are 4,
then 50 units shall be collected from initial, middle and end run of the packing operation considering time
required to pack theoretical quantity.
7.3.4 After collecting the sample, same shall be inspected for Critical, Major and Minor defects. Refer
Attachment-VIII for Critical, Major and Minor defects of various pack finish drug products.
7.3.5 Compare the results of the first inspection against the acceptance criteria as provided in Attachment-III.
7.3.6 If the number of nonconforming items found in the first sample is equal to or less than the first acceptance
number, the lot/batch shall be considered as acceptable.
7.3.7 If the number of nonconforming items found in the first sample is equal to or greater than the first rejection
number, the lot shall be considered not acceptable. In such case follow the procedure defined in the step no.
7.4.
7.3.8 If the number of nonconforming items found in the first sample is between the first acceptance and rejection
number, a second sample of the size given in the plan shall be inspected
7.3.9 The number of nonconforming items found in the first and second samples shall be accumulated. If the
cumulative number of nonconforming items is equal to or less than the second acceptance number, the lot
shall be considered acceptable.
7.3.10 If the cumulative number of nonconforming items is equal to or greater than the second rejection number, the
lot shall be considered as not acceptable. In such case follow the procedure defined in the step no. 7.4.
7.3.11 Record all the observations in the Attachment-VI or in the provision provided in the respective BPR.
7.3.12 If the results observed within the acceptance criteria, mention the remark as “Satisfactory” with sign and date
of inspector.
7.3.13 Attach the copy of filled “Pack Finish Drug Product Inspection Report” (Attachment-VI) with the respective
Batch Packing Record.
7.3.14 After completion of the inspection, handover the samples to packing officer or designee. Packing officer or
designee shall bring the defected samples to the primary packing area/cubicle, open it, repack the inspected
good bulk samples as per pack style and keep it in the respective boxes/shippers from which they are
sampled as per standard procedure. If require, withdraw the samples from last box/shipper (loose shipper, if
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

available) as the replacement sample (for defected samples destroyed) and repack them in the respective
shippers. QA inspector shall ensure the proper repacking of good samples and destruction of defected
samples. Record the activities in the “Pack Finish Drug Product Inspection Record” (Attachment-VI).
Record the quantity of defected samples destroyed after AQL sampling inspection in the respective Batch
Packing Record (BPR).

7.4 Handling of AQL failure of pack finish drug products:

7.4.1 If the results are not as per acceptance criteria, mention the remark as “Not Satisfactory, 100 % re-inspection
of the batch is to be carried out” along with sign and date of inspector in the Attachment-VIII or BPR, as
applicable.
7.4.2 Responsible Packing Supervisor shall conduct the re-inspection of the batch along with defect analysis (i.e.
type of defects) and record the activities in the respective batch packing record.
7.4.3 QA inspector shall perform the repeat AQL sampling inspection as per below procedure.
7.4.3.1 As per the batch size of the respective drug product, the sample size code letter and sample size shall be
identified by QA inspector from the AQL sampling inspection plan provided as Attachment-IV.
Note: Batch size of the pack finish drug product batch should be considered in terms of packed units as per
respective pack style.
7.4.3.2 The number of samples first inspected shall be equal to the first sample size given in the sampling plan, i.e.
Attachment-IV.
7.4.3.3 After collecting the sample, same shall be inspected for Critical, Major and Minor defects. Refer
Attachment-VII for Critical, Major and Minor defects of various pack finish drug products.
7.4.3.4 Compare the results of the repeat AQL inspection against the acceptance criteria as provided in Attachment-
IV.
7.4.3.5 If the number of nonconforming items found in the first sample is equal to or less than the first acceptance
number, the lot/batch shall be considered as acceptable.
7.4.3.6 If the number of nonconforming items found in the first sample is equal to or greater than the first rejection
number, then lot shall be considered as not acceptable. Mention the remark as “Not Satisfactory” in the
Attachment-VI and intimate the same to concern Department Head, QA Head and Plant Head. Concern
Department Head shall raise the deviation & carry out investigation as per SOP titled as “Incident Reporting
and Investigation”. Root cause analysis for the failure shall be carried out as per SOP titled “Quality Risk
Management” to find out the root cause and risk assessment shall be done simultaneously. CAPA shall be
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

taken as per SOP “CAPA (Corrective and Preventive Action) handling procedure” based on the identified
root cause or probable root cause.
7.4.3.7 If the number of nonconforming items found in the first sample is between the first acceptance and rejection
number, a second sample of the size given in the plan shall be inspected.
7.4.3.8 The number of nonconforming items found in the first and second samples shall be accumulated. If the
cumulative number of nonconforming items is equal to or less than the second acceptance number, the lot
shall be considered acceptable.
7.4.3.9 If the cumulative number of nonconforming items is equal to or greater than the second rejection number, the
lot shall be considered as not acceptable. Mention the remark as “Not Satisfactory” in the Attachment-VI and
intimate the same to concern Department Head, QA Head and Plant Head. Decision on further course of
action or disposition of batch shall be taken by QA Head in consultation with Plant Head and CQA Head.
7.4.4 The samples along with the batch shall be stored in appropriate condition with ‘Under Hold’ label as per
Attachment- XII of SOP titled as “Status Labeling” by QA department until the completion of investigation
and final decision on the batch.
7.4.5 After completion of the investigation, the defected sample shall be destroyed as per SOP titled as
“Destruction of Materials or Products”.
7.4.6 If the decision is taken for destruction of the lot, it shall be destroyed as per SOP titled as “Destruction of
Materials or Products”.

8.0 REVISION HISTORY

Version No. 00 Effective Date
Details of revision: New SOP Prepared
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-I
AQL SAMPLING & INSPECTION PLAN FOR BULK FINISH DRUG PRODUCTS
(FOR FIRST AQL INSPECTION)
Sample Acceptance Quality Limit (AQL)
Size Sample Cumulative
Lot/Batch Size Sample Critical (0.015) Major (0.15) Minor (0.25)
Code Size Sample Size
Letter Accept Reject Accept Reject Accept Reject
First 2 2 0 1 0 2 0 2
9 - 15 B
Second 2 4 0 1 1 2 1 2
First 3 3 0 1 0 2 0 2
16 - 25 C
Second 3 6 0 1 1 2 1 2
First 5 5 0 1 0 2 0 2
26 - 50 D
Second 5 10 0 1 1 2 1 2
First 8 8 0 1 0 2 0 2
51 - 90 E
Second 8 16 0 1 1 2 1 2
First 13 13 0 1 0 2 0 2
91 - 150 F
Second 13 26 0 1 1 2 1 2
First 20 20 0 1 0 2 0 2
151 - 280 G
Second 20 40 0 1 1 2 1 2
First 32 32 0 1 0 2 0 2
281 - 500 H
Second 32 64 0 1 1 2 1 2
First 50 50 0 1 0 2 0 2
501 - 1200 J
Second 50 100 0 1 1 2 1 2
First 80 80 0 1 0 2 0 2
1201 - 3200 K
Second 80 160 0 1 1 2 1 2
First 125 125 0 1 0 2 0 2
3201 - 10000 L
Second 125 250 0 1 1 2 1 2
First 200 200 0 1 0 2 0 3
10001 - 35000 M
Second 200 400 0 1 1 2 3 4
First 315 315 0 1 0 3 1 3
35001 - 150000 N
Second 315 630 0 1 3 4 4 5
First 500 500 0 1 1 3 2 5
150001 - 500000 P
Second 500 1000 0 1 4 5 6 7
First 800 800 0 1 2 5 3 6
500001 and over Q
Second 800 1600 0 1 6 7 9 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-II
AQL SAMPLING & INSPECTION PLAN FOR BULK FINISH DRUG PRODUCTS
(FOR REPEAT AQL INSPECTION)
Sample Acceptance Quality Limit (AQL)
Size Sample Cumulative
Lot/ Batch Size Sample Critical (0.015) Major (0.065) Minor (0.15)
Code Size Sample Size
Letter Accept Reject Accept Reject Accept Reject
First 2 2 0 1 0 2 0 2
9 - 15 B
Second 2 4 0 1 1 2 1 2
First 3 3 0 1 0 2 0 2
16 - 25 C
Second 3 6 0 1 1 2 1 2
First 5 5 0 1 0 2 0 2
26 - 50 D
Second 5 10 0 1 1 2 1 2
First 8 8 0 1 0 2 0 2
51 - 90 E
Second 8 16 0 1 1 2 1 2
First 13 13 0 1 0 2 0 2
91 - 150 F
Second 13 26 0 1 1 2 1 2
First 20 20 0 1 0 2 0 2
151 - 280 G
Second 20 40 0 1 1 2 1 2
First 32 32 0 1 0 2 0 2
281 - 500 H
Second 32 64 0 1 1 2 1 2
First 50 50 0 1 0 2 0 2
501 - 1200 J
Second 50 100 0 1 1 2 1 2
First 80 80 0 1 0 2 0 2
1201 - 3200 K
Second 80 160 0 1 1 2 1 2
First 125 125 0 1 0 2 0 2
3201 - 10000 L
Second 125 250 0 1 1 2 1 2
First 200 200 0 1 0 2 0 2
10001 - 35000 M
Second 200 400 0 1 1 2 1 2
First 315 315 0 1 0 2 0 3
35001 - 150000 N
Second 315 630 0 1 1 2 3 4
First 500 500 0 1 0 2 1 3
150001 - 500000 P
Second 500 1000 0 1 1 2 4 5
First 800 800 0 1 0 3 2 5
500001 and over Q
Second 800 1600 0 1 3 4 6 7
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-III
AQL SAMPLING & INSPECTION PLAN FOR PACK FINISH DRUG PRODUCTS
(FOR FIRST AQL INSPECTION)
Sample Acceptance Quality Limit (AQL)
Size Sample Cumulative
Lot/Batch Size Sample Critical (0.015) Major (0.40) Minor (0.65)
Code Size Sample Size
Letter Accept Reject Accept Reject Accept Reject
First 2 2 0 1 0 2 0 2
9 - 15 B
Second 2 4 0 1 1 2 1 2
16 - 25 C First 3 3 0 1 0 2 0 2
Second 3 6 0 1 1 2 1 2
26 - 50 D First 5 5 0 1 0 2 0 2
Second 5 10 0 1 1 2 1 2
51 - 90 E First 8 8 0 1 0 2 0 2
Second 8 16 0 1 1 2 1 2
91 - 150 F First 13 13 0 1 0 2 0 2
Second 13 26 0 1 1 2 1 2
151 - 280 G First 20 20 0 1 0 2 0 2
Second 20 40 0 1 1 2 1 2
281 - 500 H First 32 32 0 1 0 2 0 2
Second 32 64 0 1 1 2 1 2
501 - 1200 J First 50 50 0 1 0 2 0 2
Second 50 100 0 1 1 2 1 2
1201 - 3200 K First 80 80 0 1 0 2 0 3
Second 80 160 0 1 1 2 3 4
3201 - 10000 L First 125 125 0 1 0 3 1 3
Second 125 250 0 1 3 4 4 5
10001 - 35000 M First 200 200 0 1 1 3 2 5
Second 200 400 0 1 4 5 6 7
35001 - 150000 N First 315 315 0 1 2 5 3 6
Second 315 630 0 1 6 7 9 10
150001 - 500000 P First 500 500 0 1 3 6 5 9
Second 500 1000 0 1 9 10 12 13
500001 and over Q First 800 800 0 1 5 9 7 11
Second 800 1600 0 1 12 13 18 19
Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-IV
AQL SAMPLING & INSPECTION PLAN FOR PACK FINISH DRUG PRODUCTS
(FOR REPEAT AQL INSPECTION)
Sample Acceptance Quality Limit (AQL)
Size Sample Cumulative
Lot/Batch Size Sample Critical (0.015) Major (0.15) Minor (0.25)
Code Size Sample Size
Letter Accept Reject Accept Reject Accept Reject
First 2 2 0 1 0 2 0 2
9 - 15 B
Second 2 4 0 1 1 2 1 2
16 - 25 C First 3 3 0 1 0 2 0 2
Second 3 6 0 1 1 2 1 2
26 - 50 D First 5 5 0 1 0 2 0 2
Second 5 10 0 1 1 2 1 2
51 - 90 E First 8 8 0 1 0 2 0 2
Second 8 16 0 1 1 2 1 2
91 - 150 F First 13 13 0 1 0 2 0 2
Second 13 26 0 1 1 2 1 2
151 - 280 G First 20 20 0 1 0 2 0 2
Second 20 40 0 1 1 2 1 2
281 - 500 H First 32 32 0 1 0 2 0 2
Second 32 64 0 1 1 2 1 2
501 - 1200 J First 50 50 0 1 0 2 0 2
Second 50 100 0 1 1 2 1 2
1201 - 3200 K First 80 80 0 1 0 2 0 2
Second 80 160 0 1 1 2 1 2
3201 - 10000 L First 125 125 0 1 0 2 0 2
Second 125 250 0 1 1 2 1 2
10001 - 35000 M First 200 200 0 1 0 2 0 3
Second 200 400 0 1 1 2 3 4
35001 - 150000 N First 315 315 0 1 0 3 1 3
Second 315 630 0 1 3 4 4 5
150001 - 500000 P First 500 500 0 1 1 3 2 5
Second 500 1000 0 1 4 5 6 7
500001 and over Q First 800 800 0 1 2 5 3 6
Second 800 1600 0 1 6 7 9 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-V
BULK FINISH DRUG PRODUCT AQL INSPECTION REPORT

Inspection Type
(√ mark, as applicable) Initial AQL Inspection Repeat AQL Inspection

First Sample Size: Second Sample Size: First Sample Size: Second Sample Size:

Product :
Batch No. :
Theoretical Batch Size :
No. of Containers/Lots :
Sample Size :
No. of samples per
:
Container/Lot
Samples withdrawn
:
from Container nos.
Temperature & RH of
:
cubicle

OBSERVATION BY QA

Category of defects and

Defects No. of defected units observed
limit

Critical

Limit:
Accept______ Reject______

Total:
Category of defects and
limit Defects No. of defected units observed

Major

Limit:
Accept______ Reject______

Total:
Minor
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Limit:
Accept______ Reject______

Total:

Comments of QA :

Production : Name : ____________________________Sign/ Date: _____________

QA : Name : ____________________________Sign/ Date: _____________

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VI
PACK FINISH DRUG PRODUCT AQL INSPECTION REPORT

Inspection Type
(√ mark, as applicable) Initial AQL Inspection Repeat AQL Inspection

First Sample Size: Second Sample Size: First Sample Size: Second Sample Size:

Product :
Batch No. :
Pack Style :
Total No. of Boxes/Shippers :
Sample Size :
Temperature & RH of
:
cubicle
No. of samples per Samples withdrawn
: :
Box/Shipper from Box/Shipper Nos.
OBSERVATION BY QA
Category of defects and limit Defects No. of defected units observed

Critical
Limit:
Accept______ Reject______

Total:

Major
Limit:
Accept______ Reject______

Total:

Minor
Limit:
Accept______ Reject______
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Total:
Qty. of Good Samples: Packed by Sign/Date:

Re-packing of Inspected good

samples: Packed in Shipper No.: Checked by Sign/Date:

Comments of QA :

Packing Supervisor: : Name : ____________________________Sign/ Date: _____________

QA : Name : ____________________________Sign/ Date: _____________

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VII
DEFECT ANALYSIS OF BULK FINISHED PRODUCTS
Defect Analysis
Bulk Product
Critical Major Minor

Compressed ■ Wrong Embossing ■ Capping ■ Chipping

Tablets ■ Foreign Tablets ■ Cracked/Broken tablet ■ Picking/Sticking
(Mono Layer) ■ Contaminated Tablets ■ Soft Tablets ■ Dusted Tablets
■ Size variation ■ Black speck/particles ■ Rough surface
■ Illegible embossing
■ Mottling
Compressed ■ Wrong Embossing ■ Capping ■ Chipping
Tablets (Double ■ Foreign Tablets ■ Cracked/Broken tablet ■ Picking/Sticking
Layer) ■ Contaminated Tablets ■ Soft Tablets ■ Dusted Tablets
■ Layer Separation ■ Black speck/particles ■ Rough surface
■ Size variation ■ Illegible embossing
■ Mottling
Coated Tablets ■ Wrong Embossing ■ Bridging ■ Color variation
■ Foreign Tablets ■ Peeling ■ Twinning
■ Contaminated Tablets ■ Capping ■ Edge chipping
■ Size variation ■ Cracked/Broken tablet ■ Rough surface
■ Soft Tablets
■ Black speck/particles
■ Illegible embossing
■ Mottling
Hard Gelatin Capsules ■ Wrong imprint ■ Illegible imprint ■ Dusted Capsules
■ Foreign Capsules ■ Unlocked/loose locked Capsules ■ Colour variation
■ Different Cap/Body ■ Dented Capsules
■ Empty Capsules ■ Cracked/Broken Capsules
■ Size variation ■ Pinholes

Note: It's not a comprehensive list as such. Possible other defects may be observed during inspection. Defects shall be
categorized based upon criticality and end use of the product.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VIII
DEFECT ANALYSIS OF PACK FINISHED PRODUCTS
Defect Analysis
Pack Finish
Drug Product Critical Major Minor

Blister/Strip Pack ■ Over count ■ Illegible printing of text ■ Improper cutting of

■ Short count matter on Labeling/ blister/strip (not impacted
■ Wrong Labeling PIL/Pack Insert/Carton integrity of
■ Wrong Labeling text matter ■ Illegible overprinting of pocket)
■ Wrong overprinting of Product/Batch no./ Mfg. & ■ Improper alignment of
Product/Batch no./ Mfg. & Exp. Date etc. label/ Pack Insert/PIL
Exp. Date etc. ■ Improper cutting/knurling/ ■ Damaged carton/show
■ Wrong Carton/PIL/Pack Insert dropping of tablet Capsule box
■ Wrong text matter in PIL/Pack (not impacting integrity of ■ Colour variation of
Insert/Carton pocket) Carton/Label
■ Wrong/Foreign product ■ Absence of Pack Insert/PIL
■ Wrong primary packing
material
■ Improper sealing
■ Torn Pocket
Drum (Bulk) Pack ■ Wrong Container/ Closure ■ Illegible printing of text ■ Improper alignment of
■ Wrong Labeling matter on Labeling label
■ Wrong Labeling text matter ■ Illegible overprinting of ■ Improper sealing
■ Wrong overprinting of Product/Batch no./ Mfg. & drum/container
Product/Batch no./ Mfg. & Exp. Date etc. ■ Damaged
Exp. ■ Absence of filler drum/container
Date etc. ■ Improper sealing of
■ Absence of Desiccant polybag/pouch
Note: It's not a comprehensive list as such. Possible other defects may be observed during inspection. Defects shall be
categorized based upon criticality and end use of the product.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Acceptance Quality Level Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-IX
FLOW CHART OF AQL INSPECTION

First AQL

No. of Nonconforming No. of Nonconforming units No. of Nonconforming units is in

units > first rejection number between first accept & reject number
< first accept number

Lot Acceptable Inspect second sample size

No. of Nonconforming units No. of Nonconforming units

> first rejection number < first accept number

Re-inspection of lot Lot Acceptable

Repeat AQL (with stringent

acceptance criteria)

No. of Nonconforming units No. of Nonconforming units No. of Nonconforming units

< first accept number > first rejection number between first accept & reject number

Inspect second sample size

Lot Acceptable

No. of Nonconforming units No. of Nonconforming units

> first rejection number < first accept number

Raise the Incidence & Investigate Lot Acceptable