SOP for acceptable quality level (AQL) -

SOP for acceptable quality level (AQL)

1.0 PURPOSE:

To lay down procedure for conducting Acceptable Quality Level (AQL) for products at various stages; including Compression, Coating and Capsule filling.

2.0 SCOPE:

This procedure conducting Acceptable Quality Level (AQL) is applicable to the Pharmaceutical Manufacturing Facilities in oral solid dosages of (Company name).

3.0 DEFINITIONS:

3.1 Acceptable Quality Level, also known as AQL or assured quality level, is an inspection standard describing the maximum number of defects that could be considered acceptable during the random sampling of an inspection.
3.2 Foreign Matter: Any contaminant (material that is not a part of the normal process), either physical or chemical, that is found or suspected to be in an excipient, API, or finished clinical drug product.
3.3 Critical Defect: A defect that presents a safety concern to the user, fails internal and/or cGMP specifications, renders the product unfit for use.
3.4 Major Defect: A defect that is not a safety concern to the user and conforms to internal and/or cGMP specifications but may make product difficult to use or render the product unfit for use.
3.5 Minor Defect: A defect that is not likely to reduce materially the usability of the unit of product for its intended purpose. While these defects are departures from established standards, they have little bearing on the effective use or operation of the unit of product.
3.6 Embedded surface spots: Clearly defined particles which are embedded in or on the surface of the tablets. The particles (spots) are foreign, extraneous, or contaminant to the tablets.
3.7 Splitting: A complete separation of the tablet into two or more substantial parts.
3.8 Possible splitting (Cleavage): An identification or “weak” point on the vertical surface of the tablet which may result in splitting of the tablet.
3.9 Capping/Possible capping (capitation): The separation (or tendency toward separation) of a portion of the upper or lower surface of the tablet.
3.10 Cracks: A break in the surface of the tablet.
3.11 Broken: The separation or dislodging of more than 10% of the tablet weight.
3.12 Overturned (projected) edge: The excess ridge at the point where the “face” (convex or flat surface) meet the vertical surface of the tablet. This ridge (projection) is more than 10% of the vertical length.
3.13 Feathered edge: Similar to an overturned edge except that the ridge resembles somewhat the teeth of a saw and the ridge is not 10% of the vertical length.
3.14 Adhering surface spots: Clearly defined particles which adhere to the surface but can be wiped or blown off the surface. The particles (spots) are foreign, extraneous, or contaminant to the tablets.
3.15 Pitting (porous): small indentation in the surface of the tablet.
3.16 Chips: An indentation on the edge of the tablet. The cross section (largest dimension) of the chip in the tablet is more than 10% of the tablet weight.
3.17 Die spots: The small indentation in the surface of the tablet such as that caused by a sticking to the punch or die, or the result of a gummed punch or die.
3.18 Flaking: A peeling or separation of coating from any area of the tablet.
3.19 Erosion: stripping away or dissolving of the film coating or layers of the sugar coating resulting in a loss of the coating integrity.
3.20 Non uniform color: The irregular coloration of the tablet.

4.0 RESPONSIBILITY:

4.1 IPQA – Shall be responsible to perform the AQL after process completion.
4.2 Production personnel – Shall be responsible to ensure the inspection incase of AQL failure.
4.3 Head QA – Shall be responsible to ensure the compliance as per SOP.

5.0 PROCEDURE:

5.1 After completion of process, Production personnel shall inform to IPQA for AQL performance. (Compression/Coating/Capsule Filling)
5.1.1 If the final product is un-coated (core), uncoated tablets shall be subjected to AQL by collecting sample from all the containers
5.1.2 If the final product is coated, coated tablets of every lot shall be subjected to AQL by collecting the sample from the coating pan
5.1.3 If the final product is filled capsule, AQL is performed at final process stage by collecting sample from all the containers
5.2 Sampling and inspection procedure for AQL:
5.2.1 Product shall be sampled as described in the point numbers 5.1.1 to 5.1.3
5.2.2 The sample quantity shall be determined as described in Annexure-I (Prepared as per ANSI/ASQ/ Z1.4-2008 standard, Normal Inspection Level II sampling tables).
5.2.3 Sampled product shall be collected in clean pre-labeled containers or self-sealing polybags.
5.2.4 Collected samples shall be subjected to inspection.
5.2.5 QA personnel shall inspect all units from the samples under adequate lighting.
5.2.6 Inspectional aids such as Inspection pad, Magnifying glass, torch light, inspectional aids cards etc shall be used where applicable for effective inspection.
5.2.7 Each unit shall be subjected to inspection on either side including top and bottom sides.
5.2.8 QA personnel shall verify each unit and observe for defects as mentioned in the Annexure-II for compressed or uncoated tablets, Annexure-III for coated tablets and Annexure-IV for filled capsules.
5.2.9 Observed defects shall be properly segregated.
5.2.10 The total % of Acceptance Quality Level checks results shall be evaluated to confirm with Critical defects, Major defects and Minor defects as defined below:
5.2.10.1 Critical defects: (0.0 %)
5.2.10.2 Major defects: Not more than 1.0 %
5.2.10.3 Minor defects: Not more than 4.0 %
5.2.11 After completion of AQL, if the percentage of rejection is within the acceptance criteria, the good tablets/capsules shall be released to the next stage.
5.2.12 Sample quantity for analysis shall be collected from the AQL pooled sample and the remaining tablets/capsules shall be added to the last container of the batch, defected tablets/capsules shall be rejected.
5.2.13 If AQL failure due to minor/major defects, all the containers of the batch shall be quarantined and shall be recommended for 100% inspection and shall be recorded in BMR.
5.2.14 If AQL fails due to critical defects, further activity shall be carried out as per failure investigation.
5.2.15 Respective batch given for 100% inspection for compressed tablets/coated tablets and filled capsules, Production personnel shall perform the inspection of the batch.
5.2.16 Repeat the AQL and submit the sample for analysis from the pooled sample.
Note: If AQL for critical non conformities fails, it shall be informed to the Head QA/ Designee and further investigation shall be carried out as per the failure investigation. Investigation shall be performed by production and QA personnel (If required FR&D help can be sort) to find the root cause. Based on the outcome of the instigation Head QA shall decide disposition of the batch.
5.2.17 If any customer / third party (Contract giver) specifies acceptance criteria for AQL, the same shall be included in the batch manufacturing record of the respective product.

6.0 ABBREVIATIONS:

AQL : Acceptable Quality Level
SOP : Standard Operating Procedure
QA : Quality assurance
BMR : Batch manufacturing record
cGMP : Current good manufacturing practice

7.0 REFERENCES:

7.1 ANSI/ASQ Z1.4-2003 (R2018): Sampling Procedures and Tables for Inspection by Attributes.
7.2 ISO 2859-1:1999 Sampling procedures for inspection by attributes.

8.0 LIST OF ANNEXURES:

Annexure-I: Sampling plan and acceptance criteria for tablets and capsules.
Annexure-II: Uncoated Tablet (core) Classification of Defects.
Annexure-III: Film Coated Tablet Classification of Defects.
Annexure-IV: Hard Filled Capsule Classification of Defects.
Annexure-V: Sampling plan for physical verification.