in today’s post i am going to write in details which points should be covered step by step , in making your Annual product quality review of a pharmaceutical product.
First page provide summary of details about APQR
Review Period: Jan 2010to Dec.2010
S.O.P No : ABCD ——– Here you will find SOP for annual product reveiw
Ref No: APQR /PRODUCT NAME
Prepared by :QA person
Checked by :QA person
Approved by : QA manager.
On subsequent pages write other detailed information.
Which points are required to be covered for review of pharmaceutical
So many number of batches of Pharmaceutical product manufactured during the
period (JAN.2010 TO DEC 2010) were reviewed .
The summary of the review and finding is as under.
1.1 During the review period, no major process modification was done and the process was under control. There was no change in the batch size. (write in detail if there is any change)
1.2 There was no manufacturing process related problem encountered during the
review period. (write in detail if there is any change)
1.3 The data obtained for the environmental monitoring indicates that the area was
under control and there were no fluctuation in the working environment.
1.4 The product manufactured were well within the specified limits.
1.5 Quality review studies indicate that the product is within the specified limits.
1.6 Review of filling and packing activities indicate that the filling and packing
operations are under control during the review period.
1.7 There were certain documentation observed during review period. These lapses
were discussed with the concern technical personnel’s.
1.8 write in detail if there is any change in labeling and content .
1.9 Process validation was done during the review period and Equipment Review was carried out during review period. (Write your validation report number .)
2.0 RECOMMENDATION /CONCLUSION
2. 1 Batch manufactured during the review period showed that the process was under
3.0 FORMULATION OF PHARMACEUTICAL PRODUCT /
example paracetamol 500 mg per tablet .
Write Raw material dispensing Detail sheet , with quantities and pharmacopoeial status of the materials , Quantity per batch , label claim , overages etc.
Write if you are adding any of raw material considering its potency or assay ,
Write formula for calculation.
4.0 BATCHES REVIEWED
You have to select the batches , i have written about how this should be done in my earlier post , what are the criteria for batches to be selected for review.
During the review period there were no reprocessing and FDA recalls of the product
Following batches manufactured in different months are selected for review. write in details if there is any reprocessing or recalls .
Write Batch numbers Manufacturing Date Expiry Date
001 ————– Jan 08—————– Dec 2010
002 ————– Jan 08—————– Dec 2010
003 ————– Jan 08—————– Dec 2010
004 ————– Jan 08—————– Dec 2010
During the period of review . there was change in the Batch manufacturing Record
(Write in details if there is any change)
5.0 REVIEW OF BATCH MANUFACTURING RECORD.
Write if any observations about BMR any corrections , and corrective action about BMR .
5.1.The manufacturing steps have been carried out as per the manufacturing instruction.
5.2. All rejection destroyed under supervision of Competent Technical Person
Write in Tabular form % yield of the batches selected against the batch number.
Conclusion : Yield of all the batches taken for the product review is well within the Specified limit of yield
WRITE PACK SIZE AND THE PRICES AND CHANGE IF ANY
6.0 REVIEW OF PACKING
6.1. Reconciliation details of bottles and Labels of all the batches reviewed were found
6.2. Batch details on the labels against overprinted instruction were found satisfactory
B. No MFG Date, EXP Date & MRP (Inclusive of all taxes) of manufacturing found
6.3 Filled values were checked and recorded during packing at regular intervals
7.0 ENVIRONMENTAL MONITORING
(write about your monitoring system and reports)
Environmental monitoring was carried out by settle plates, on regular basis.
The results obtained were satisfactory during the review period are as follows.
(ALERT LIMIT: NMT50 CFU/PLATE ACTION LIMIT: 100CFU/PLATE )
Write your observations in tabular form.
7.1 The data obtained for the environmental monitoring indicates that the area
was Under the control and there were no fluctuation in the working environment.
CONCLUSLION: The microbial count of the environment during the
manufacturing process is well within the specified limits.
8.0 REVIEW OF ANALYTICAL RESULTS
During the review period following batches were analysed for active ingredients as per finished product specification no XYZ
Write in tabular format , Assay of each active ingredients with their limits of passing ,against batch numbers considered for review.
OOS results and its report , if you get any OOS result what were your steps to find out the reason , list out the complete criterias for acceptance , investigations of OOS
AGE WISE STUDY OF ACTIVE INGREDIENTS AS ON DATE OF ANALYSIS :
Write in tabular format , Assay of each active ingredients with their limits of passing ,against batch numbers considered for review , AFTER A PARTICULAR AGE WHILE IN STABILITY.
1. No out of specification results observed in the batches during the review period.
1 There was no changes in raw material specification during the review period of time.
2 There was no change in the packing material specification
3 There was changes in the specification of finished product during review period.
4. There was no changes in the supplier and manufacturer of the raw materials and New Supplier is introduced for packing material
Microbial limit test is performed on every batch .
Total viable count Aerobic Count NMT 1000 CFU /ML
Total viable fungal ——NMT 100 CFU /ML
Write your results in tabular format.
1. All batches during review period were analysed according to the product quality Specification No
– The results obtained was found within specified limits.
2. All batches manufactured during the review period were passed as per the released specification
3. Microbial limit test was carried out on every fifth batch and found within the limits.
4. The results of the active ingredients were found within specified limits.
8.0 VALIDATION & CALIBRATION REVIEW
1. Calibration of the manufacturing equipments used for the manufacturing of the pharmaceutical product has been done.
2. During the review period calibration of the following instruments was carried out regularly as per as per SOP .Results found satisfactory
Instruments ————————————–SOP NUMBER.
PH Meter Calibration (Daily Calibrated) : SOP NUMBER
Balances (Daily Calibrated) :SOP NUMBER
HPLC (Detector (Six moths), SOP NUMBER
Pump (3 months Calibrated) : SOP NUMBER
FTIR Spectrophotometer( 3 Month) :SOP NUMBER
10 MARKET COMPLAINTS:
write in details market complaints if any and action taken to prevent them.
No market complaint has been received during the review period.
11. REVIEW OF TECHNICAL DOCUMENTS:
Finished product Specifications.
Raw material specifications
Packaging material specifications
Licence and certifications
write supportive documents reference numbers and sop number so as to produce traceability of each and every documents.
Annual Product Quality Review document should Include All batches of pharmaceutical products.
This website is a guide for pharmaceutical manufacturing pharmacy students and industrial pharmacists