This document shows only a few examples of market complaint with the suggested investigation. When a QC complaint and the QC ticket is created, Sales Dept. and Purchase Dept. must check under which of the below complaints it pertains to and follow the guideline. Purchase Dept. should gather as much information as possible according to the guideline.
Ineffectiveness / Poor Quality / Inadequate Response of the Drug
Less Content in Capsules / Vial/ Ampoules / Bottle
Bulging of Strip Pockets
Presence of Foreign Matter (Living / Non-Living)
Adverse Reactions
Discoloration of Solution or Tablet / Capsule
Damaged / Broken / Leaking Capsule
Broken Tablet
Melt Back (of Lyophilized Cake)
Product or Batch Mix Up
Poor Quality of Cap (Dropper), Applicator
Fake Product
Empty Primary Container (Vial / Ampoule / Bottle / Pocket of Strip or Blister)
Receipt of Product in Different Show Box / Having Different Label
Count Variation of Tablets and Capsules in Bottles
Non-Working Devices (Auto-Injector Pens, Prefilled Syringes or Devices for Inhalation)
Missing Label / Missing Batch Details
1. Ineffectiveness / Poor Quality / Inadequate Response of the Drug
History of the product.
Physical inspection of complaint and control sample.
Review of batch document for,
Active RM calculation.
added of active and inactive RM (MRO and Coupons) against bill of material.
Source of material.
Dispensing precautions: e.g. API dispensing and storage in the black/ light resistant bag or container.
Processing precautions: e.g. dissolved oxygen, low light, nitrogen flushing or any other.
Processing parameters.
In-process checks by production and QA.
Daily quality observation record.
Any deviation, which has direct or indirect impact on product quality.
In-process quality control data.
Review of FP analytical report and trend.
Review of stability data.
Complaint and control sample analysis for,
Volume variation,
Content uniformity.
Moisture content.
Storage condition.
2. Less Content in Capsules / Vial/ Ampoules / Bottle
Physical inspection of complaint and control sample,
For minor crack.
Improper sealing.
Condition of container label and/or show box to eliminate the possibility of leakage.
Review of batch manufacturing record for,
Active RM calculation
added of active and inactive RM (MRO and Coupons) against bill of material.
In-process checks by production and QA
Visual inspection record.
Leak test record.
Yield and reconciliation of the batch.
In-process and FP quality control data.
Trend of yield.
Sequential log of filling or compression or capsule filling machine for the breakdown.
Daily quality observation record.
Market Complaint and control sample analysis for,
Content uniformity.
Volume variation.
3. Bulging of Strip Pockets
History of the product.
Physical inspection of control and complaint sample.
Improper storage condition.
Review of stability data.
Review of Packing material Quality.
Analysis of complaint sample for
4. Presence of Foreign Matter (Living / Non-Living)
History of the product.
Physical inspection of complaint and control sample for,
Minor crack.
Improper sealing.
Daily quality observation record.
pH trend (to correlate with the leaching from the container).
Physical inspection of RM / PM of particular AR No. used for manufacturing of the batch.
Review of batch manufacturing record for,
Use of pretreated ampoules (e.g. acid-treated amps).
Empty primary Pkg. material washing and sterilization in the record.
Cleaning record of manufacturing, filtration and filling equipment, and area.
Sterilization record of filtration and filling equipment.
Filter integrity test results (Pre and post-filtration)
Leak test record.
Terminal sterilization record.
Sequential log of washing machine.
Environmental monitoring data.
Quality/compatibility of closure.
Microbiological analysis of complaint sample.
Training record of visual inspectors.
5. Adverse Reactions
Review of complaint history
History of the patient.
Review of the package insert.
Microbiological analysis of complaint sample.
Pharmacology of the API and related formulations.
Analysis of complaint/control samples for :
Assay / Dissolution
Related Substances.
6. Discoloration of Solution or Tablet / Capsule
History of the product.
Physical inspection of complaint and control sample for,
Minor crack.
Improper sealing.
Review of batch manufacturing record for,
Special precautions required during processing e.g. dissolved oxygen, low light, nitrogen flushing or any other.
Cleaning record of manufacturing, filtration and filling equipments and area.
Leak test record.
Terminal sterilization record.
Daily quality observation record.
Recovery procedure.
In-process checks by production and QA during manufacturing and packing.
Analysis of control and / or complaint sample for,
Stability data.
Storage condition.
7. Damaged / Broken / Leaking Capsule
Physical inspection of complaint and control sample.
Review of batch manufacturing record for,
Visual inspection record and humidity conditions.
Cap filling machine setting parameters.
In-process checks during manufacturing and packing by QA and production.
Vendor of the empty capsule.
Sequential log of capsule filling machine for the breakdown.
Training of the visual checkers.
Compatibility study of empty hard gelatin cap with excipients.
Monitoring of defoiling and repacking activity.
8. Broken Tablet
History of the product.
Physical inspection of complaint and control sample.
Review of batch manufacturing record for,
In-process checks by production and QA during manufacturing and packing.
Visual inspection record.
Review of the trend of processing, in-process and FP parameters.
Daily quality observation record.
Handling of the bulk product.
Training record of the visual checkers and strip packing machine operators.
Analysis of control and/or market complaint sample for monitoring of de-foiling and repacking activity.
9. Melt Back (of Lyophilized Cake)
History of the product.
Physical inspection of control and complaint sample.
Review of batch document for,
Filling in-process checks by production and QA
Lyophilization menu.
Visual inspection record.
Hold time at different stages.
and humidity conditions at different stages.
Review of trend of processing, in-process and FP parameters.
Daily quality observation record.
Review of stability data.
Analysis of complaint and/or control sample for,
Moisture content
Degradation
Training record of visual inspectors.
10. Product or Batch Mix Up
Physical inspection of control and complaint sample for physical appearance of primary pkg. the material of two products under question.
System followed to ensure proper segregation products at different stages.
Sequential log of machine at every stage to know the previous or next product taken on the same machine and to ensure absence of same /similar product in the surrounding area.
Other products packed on the same day on the nearby labeling machine or packing line of the product under question.
Review of batch manufacturing record for,
Machine and line clearance record at different stages.
Reconciliation of packaging materials.
Reconciliation of bulk and FP.
Analysis of control and complaint sample (if available) for,
Identification test of two products under question.
Wrong labeling/packing.
Daily quality observation record.
Monitoring of de-foiling and repacking activity.
Training record of packers.
Repacking if done at any C and F location.
11. Poor Quality of Cap (Dropper), Applicator
History of the product.
Physical inspection of control and/or complaint sample.
Vendor of pkg. (cap or dropper) material.
Compatibility study.
Review of stability data.
12. Fake Product
History of the product.
Comparison of complaint sample with control sample for the appearance of strip/ label (font size of letters, printed text matter, size of the pocket, the gap between the two pockets, knurling pattern, the logo of the company, movement of tab or cap in the pocket, etc).
Market complaint sample with control sample for appearance of tablet or capsule (size or dimensions, color, imprint, embossing, edge type, etc).
Comparison of primary packaging material (Vial / ampoule) for shape and size, amp. sealing height, type of seal, logo on the seal, color of the seal, type of rubber stopper, etc.
Analysis of control and complaint sample (if available).
13. Empty Primary Container (Vial / Ampoule / Bottle / Pocket of Strip or Blister)
Physical Inspection of control and complaint sample (if available).
Sequential log of filling or striping or blistering machine for
Review of batch document for,
In-process checks by production and QA during filling
Leak test record.
Visual inspection record.
In-process checks by production and QA during packing (e.g. on line compressed air flow or any other system followed to remove empty plastic container or empty pocket in strip or blister).
Yield and reconciliation of the batch and comparison with trend.
Balance performance and calibration check record.
Weight variation record of packed show boxes and/or shippers.
Proper segregation of packed and empty boxes.
Daily quality observation report.
Training record of the visual inspectors.
Vendor of the primary container (as the cause of empty container may be hairline cracks due to weak MOC of the container).
14. Receipt of Product in Different Show Box / Having Different Label
Complaint sample observation.
Physical inspection of control sample.
Previous and next product packed on the same machine.
Appearance of packing material of two products under question.
Review of batch document for,
Line clearance (by packing and QA) record.
Reconciliation of packing material.
Machine and line clearance record.
In-process checks by packing and QA.
Daily quality observation record.
Storage of packing material in the store and in pkg. Dept.
Procedure to be followed for the leftover pkg. The material after completion of packing.
Monitoring of de-labeling and relabeling/ repacking activity.
Inspection of the remaining stock of PM of the products under question.
PM vendor audit.
Training of packers.
Repacking if done at any C and F location.
15. Count Variation of Tablets and Capsules in Bottles
Physical Inspection of control and complaint sample (if available).
Sequential log of filling machine for the breakdown.
Review of batch document for,
Startup clearance.
In-process checks by production and QA during filling
Leak test record.
Visual inspection record.
Challenge tests/performance check for the sensors on line.
In-process checks by production and QA during packing (e.g. on line compressed airflow or any other system followed to remove such container).
Yield and reconciliation of the batch and comparison with the trend.
Balance performance and calibration check record.
Weight variation record of packed show boxes and / or shippers.
Proper segregation of packed and empty boxes.
Daily quality observation report.
Training record of the visual inspectors.
16. Non-Working Devices (Auto-Injector Pens, Prefilled Syringes or Devices for Inhalation)
Physical Inspection of control and complaint sample (if available).
Sequential log of filling / assembling machine for the breakdown.
Review of batch document for,
Startup clearance.
In-process checks by production and QA during filling
Leak test record.
Visual inspection record.
Challenge tests/performance check for the sensors on line.
In-process checks by production and QA.
Yield and reconciliation of the batch and comparison with trend.
Performance check record during assembling / filling.
Daily quality observation report.
Training record of the visual inspectors.
17. Missing Label / Missing Batch Details
Complaint sample observation.
Physical inspection of control sample.
Review of packing materials used for packing of the batch.
Review of batch document for,
Line clearance (by packing and QA) record.
Reconciliation of packing material.
Machine and line clearance record.
In-process checks by packing and QA.
Performance check for sensors on line.
Daily quality observation record.
Storage of packing material in the store and in pkg. Dept.
Procedure to be followed for the leftover pkg. The material after completion of packing.
Monitoring of de-labeling and relabeling/ repacking activity.
Inspection of the remaining stock of PM of the products under question.
PM vendor audit.
Training of packers.
Repacking if done at any C and F location.
Note: Processing parameters include:
Quality of input material.
Source of input material (vendor).
Quality of purified water and water for injection.
Nitrogen flushing.
Mesh size of the sifter, direction of knife.
Mixing speed and time.
Speed of mill and screen size used during milling.
Type (MOC) of the filter used.
Drying inlet and outlet temp. time, endpoint (LOD).
Lubrication time, rpm of blender.
Speed of compression machine.
Dissolved oxygen and Humidity conditions at different stages.
Ampoule sealing height.
Sterilization cycle of empty primary containers.
Porosity of filter used.
Granulation time and qty. of binder consumed.
Terminal sterilization cycle.
Pre and post integrity test results of the filter.
Leak test cycle.
Strip packing machine speed of sealing roller.
Hold time at different stages.
Lyophilization cycle.
Any special precautions to be taken like manufacturing under low light.