sop for annual quality review


sop for annual quality review




To lay down a procedure to review all parameters which affect the quality and safety of products annually and decide the remedial actions for improvements.


Quality Assurance Executive


Head – Assurance




Total number of batches manufactured in the annual calendar shall be evaluate for the number of deviations occur as given in the following template

No. of Product Manufactured :
No. Batches Manufactured :
No. of batches Failures :

1. Summary of Batches Manufactured:

Sr. No.

Product Name

Code No of Batches Manufactured No. of



2.0 Process Deviations:

Total number of batches manufactured shall be evaluated for the product and batch number for nature of process deviations and such

type of deviations shall be recorded in the following template.

Deviation No. Name of Product & Batch Number Nature of Deviation

3.0 Market Complaints

Compilation of total market complaint received during the year shall be
Categorise and mention the number of complaints received and make conclusive remark and corrective action.


Code No. Category No. of Complaints

4.0. List of Rejected Raw and Packaging Materials

The Annual Rejection of the raw and Packaging Material shall be summerised to evaluate the performance of the vendors

and corrective actions to prevent the recurrences with conclusive remark for discontinuation if required in the following template.

If re audit is required then prepare a calendar for re audit.

Item Code

Item Name

Reason for rejection Manufactured By


5.0 Vendor Reassessment:

If rejection trend observed frequently of any supplier then reassessment should be evaluated .


6.0 Stability Studies
Samples kept for stability of new product, first batch of the year, or for any reason and failures during stability

should be evaluate in the following template.

Sr. No. Total Batches under stability Studies No. of Batches
1 New Products added during year
2 First batch of the year
3 Any other reason, than i ) & ii)
4 Failure/ Reported during these year

7.0 Change Control Approved

Total Number of change controls filled during the year shall be categorise and conclusive remark should be made by using following template.

Sr. No. Type of change Nos.
1. Facility related  
Equip/Machine Related
3. Systems  





8.0 Qualifications:

Qualification or re-qualification of all production equipments have done in the year shall be evaluated for out in the Annual Quality Review.

9.0 Process Validations:

All the process validations performed in the year shall be evaluated. All the process parameter, which can effect validated process,

change of approved vendor for Active ingredient.

Annual product review shall be carried out to evaluate the product behavior over a period of time, which are manufactured as per the validated process.

10.0 Cleaning Validation:

Cleaning procedure validation which are carried out at Alkem shall be summarized in order to ensure the cleaning procedure is effective.

11.0 Computer Validation:

While compiling the data last year data shall also be accounted for comparison purpose, which will indicate the trend towards the improvement or deterioration of Quality.

12.0 Out Of Specification:

All the Out Of Specifications shall be evaluated for comparison purpose in the following format.

Sr. No.

Type / Stage

A. Laboratory related  
B. Mfg./Packing related  
C. Raw Material Related  
D. Packaging Material Related  


13.0 Calibration:

Annual calibration Schedule of Various Gauges of 2002

Annual calibration Schedule of 2002 – Lab. Equipment, shall be reviewed and shall be noted for any Out of Calibration Incidents.

14.0 Training:

The training topic coverd in the year shall be reviewed and based on this the training calendar for next year shall be prepared.

15.0 Environmental monitoring Control:

Environmental Monitoring control shall be reviewed i.e. for settle plate monitoring as well as by active-air sampling shall be reviewed and

the same shall be recorded in the format given below.

Grade Locations No. of samples

From: Sept.2001 to


No. of samples

Within alert limit

% No. of samples

above alert limit

% No. of samples

Above action limit




The From the establishment of this plant and the microbiological laboratory till date more than 800 samples of sterility test have been

carried out in accordance with Standard Operating Procedure for sterility test (reference A/QA/109). The method followed is membrane filtration type using 0.22µ membrane filter.

Total number of samples analyzed From —————

Total no of samples:


Summary of Self Inspection Reports – Year

No. of Audits Conducted :
No. of Departments Audited :


No. of non-conformances



Findings Complied Pending for Compliance Findings Complied Pending for Compliance Findings Complied Pending for Compliance

Remark: Compliance of the point still pending, compliance shall be reviewed during the 1st audit of the department due in 2003.

17.0 Quality improvement Plan

Improvement plan for next year shall be mentioned while preparing the Annual Quality Review.


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