SOP for Conducting Acceptable Quality Levels

PURPOSE

To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing.

SCOPE

This SOP applies to all tablet products manufactured at the plant.

RESPONSIBILITY

IPQA/Production Officer

• IPQA officer and the production officer shall be responsible for sampling
• Performing the Acceptable Quality Level (AQL)

Production Manager

Responsible for checking and authorizing the same.

QA Manager

Responsible for compliance with this SOP

PROCEDURE

• Wear hand gloves and a nose mask before sampling and while performing the Acceptable Quality Level (AQL)
• AQL sampling and inspection should be done as per the requirement of the product at different stages of manufacturing, viz., initial parameter checks of compression, parameter checks during compression, and parameter checks after coating, inspection of tablets or after filling/sorting of capsules
• The AQL sampling and 'accept/ reject' criteria should be decided according to the lot size /batch size, and it should be given in the respective Annexure.
• Samples should be withdrawn from the container or coating pan as per the sampling plan.

• If all observations are within the limit, the lot/batch can be released for the next stage of the process.
• Suppose the number of unacceptable units found in the sample is equal to or exceeds the rejection criteria. In that case, the IPQA officer shall record the same and shall tick 100% inspection in the result column of the AQL format. This situation can arise due to the following:

1. If the number of major /minor rejects is on the higher side
2. If the results of AQL do not comply with the acceptable level. It shall be checked by the section head of production and authorized by the section head of QA (first 100% inspection in case of Uncoated tablets or second 100% inspection in case of coated tablets).

• After 100% inspection of the batch/lot, collect the sample as per the sampling plan, follow the" sampling plan and acceptance criteria for tightened inspection," and perform AQL on the same.
• Suppose the number of unacceptable units found in the sample is equal to or exceeds the rejection criteria. In that case, the IPQA person shall record the same and shall tick 100% inspection in the result column of the AQL format. It shall be checked by the section head of production and authorized by the section head of QA (2nd 100% inspection in case of uncoated tablets or 3rd 100% inspection in case of coated tablets).
• Suppose the number of unacceptable units found in the sample is equal to or exceeds the rejection criteria. In that case, the IPQA officer shall record the same and tick rejection in the result column of the AQL format. Deviation shall be raised as per SOP " Handling of deviation," and the batch will be segregated for the final disposition by Head QA
• If any critical defect is observed at any stage of AQL, the IPQA officer shall record the same and tick rejected in the result column of the AQL format. Deviation shall be raised as per "Handling of deviation," and the batch will be segregated for final disposition by the Head QA.
• Rejects of AQL analysis should be disposed of as per SOP, while good tablets after AQL inspection should be added to the respective lot/ batch.

Initial Compression Parameter Checks

• In initial checks, inspection level should be S-4 with AQL criterion of 0.065, 1.5 & 4.0 for critical, major, and minor defects, respectively, at 'Normal' level (Level of severity of inspection) with 'Single Sampling Plan'
• Depending upon this AQL criteria, the sample size & 'accept/ reject' of defective sample will be set according to lot/batch size, by referring to the AQL inspectors' rule or as per Annexure 1
• After initial setup, collect the samples of tablets from both sides of the machine (whenever applicable) and inspect visually for the defect as mentioned above.
• Note down the number of defective tablets in the annexure for the respective level and decide on acceptance/ rejection of the sample
• Example for referring to the AQL chart (available in Annexure) for initial checks:

1. Consider that the batch size is 50,000 Nos and select the same in the batch or lot size window of the AQL chart. For this batch size, select 'S-4' as inspection level among seven inspection levels (I, II, Ill, S1, S2, S3 &S4)
2. As the batch size and inspection level are fixed, check the sample size code letter in the window of the AQL chart, which comes to be 'J'.
3. Check the sample size (which comes to be 80) against the code (J) for individual type of reject along with a number of defective samples for acceptance or rejection of AQL, which will be as per the following table:

ALSO READ: SOP for Annual Product Quality Review

Table I: Example AQL for 50,000 batch size

AQLS	Sample Size	Accept	Reject
Critical   0.065	80	0	1
Major     1.5		3	4
Minor     4.0		7	8

NOTE:

1. Accept: Number of Maximum defective samples allowed to pass the AQL criteria.
2. Reject: Number of Maximum defective samples allowed to fail the AQL criteria.

In Process Checks during Compression

• During in-process checks, inspection level should be 'I' with AQL criterion of 0.065, 1.5 & 4.0 for Critical, Major & Minor at 'Normal level' (Level of severity of inspection) with 'Single Sampling Plan'.
• During the compression run, take the sample for AQL analysis.
• Frequency should be decided as per the respective Product, considering the machine speed and total operation time of the process.
• Calculation of the quantity of units for in-process sampling should be done as follows:

Where,

X = Number of units

A = Total cumulative samples as per Annexure No.

B = Total production time in minutes

C = Frequency in minutes

• In case of a double rotary machine, half the quantity of samples is to be withdrawn from each side of the machine.
• The calculated quantity should be rounded off towards the higher side.
• Visually inspect the samples for the defects as mentioned.

After Coating

• After coating (for each lot), inspection level should be 'I' with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at 'Normal level' (Level of severity of inspection) with 'Single Sampling Plan'.
• Follow the AQL inspector's rule as per Annexure-II to decide the sample size and number of tablets to be accepted and rejected.
• Note down the number of defective tablets in the Annexure for the respective level and decide on acceptance or rejection of the sample.

Uncoated Tablets for Packing

• Before packing (for each lot/container), inspection level should be 'I' with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at 'Normal level' (Level of severity of inspection) with 'Single Sampling Plan'.
• Follow the AQL inspector's rule as per Annexure - II to decide the sample size and number of tablets to be accepted and rejected
• Note down the number of defective tablets in the Annexure for the respective level and decide on acceptance or rejection of the sample.

Classification of defects to be done as follows

	Critical	Major	Minor
Compressed Tablet	Foreign Particles Foreign Tablets Incorrect color, size or shape Chipped Tablets Incorrect debossing	Broken tablet Wedge edges Chipped Capped Mottled Black or oil spot	Indistinct spots Slight Burr Slightly Rough edges Sticking
Coated Tablet	Incorrect Colour Foreign Tablets	Chipped tablets Sticky tablets Obscure inprints Tablets not polished	Spots Tablets not smooth Surface blemishes

ANNEXURES

Nil

ABBREVIATIONS

AQL: Acceptable Quality Level

IPQA: In-process Quality Assurance

QA: Quality Assurance

SOP: Standard Operating Procedure

REVISION HISTORY

Nil

ALSO READ: SOP for the Preparation of the Master Formula Record