Quality Control

DESCRIPTION OF THE QUALITY CONTROL SYSTEM AND OF THE ACTIVITIES OF THE QUALITY CONTROL DEPARTMENT PROCEDURE FOR THE RELEASE OF FINSHED PRODUCT:

Short description of quality management system of the firm:

Maintenance of quality can be achieved by the combined efforts of Production & Quality Control wing.  For Quality Management, the firm has a quality control unit which has the responsibility & authority to approve or reject all the components, drug product containers closures, in process materials, packing materials, labeling & drug product & the authority to review production records to assure that no errors have occurred and that they have been fully investigated.  The quality control unit is responsible for approving or rejecting drug products manufactured, processed, packed or held under contract by another company.  Adequate laboratory facilities for testing & approval or rejection of the components, drug product containers, closures packing materials, in-process materials & drug products are available with the quality control unit.  Most of the operations carried out in production & quality control wing are as per the specified written procedures.  The head of quality control wing is independent of the head of production wing.  On receipt of any raw materials or packaging material etc., outer covering like jute bag or any particle shedding outer covering is removed.  The consignment is checked for any damage to the supplies during transit.  The Q.C. Wing is intimated of the receipt of the goods.  Authorized person from Q.C.D. comes to the store & verifies the information given on the container with regard to product name, batch no., mfg., exp., and mfd. By, no. of containers & tallies it with the concerning documents.  Leakage or damage (if any) is ruled out.  Any gross deviation is brought to the notice of the Q.C. Manager & if deemed fit the consignment is rejected & returned forth with.  If found O.K. sampling from various containers is done by the Q.C. person by the standard procedure as sampling plan & the testing is commenced as per the specified pharmacopoeial or in house specification. Yellow coloured under test slips are pasted on the consignment and when found O.K. Green, approved slips signed and dated by Q.C. In-charge are pasted on the containers and if not complies to specification, Red rejected slips are pasted on the containers.  They are segregated to rejected material store & returned to the supplier at the earliest.  Q.C. Deptt. Personnel are authorised to draw samples from various stages of manufacture & ascertain whether the specified methods have been followed in full.  Sample of finished goods is drawn from various stages of production & the goods analysed as per specified procedures and specifications. 

Intimation of its results is sent in writing and any material in doubt is withheld till confirmation of its result and release by Q.C.D.   The approved testing laboratories carry out any test for which facilities do not exist and the co-ordination is done by the Q.C. Deptt.   The Q.C. Deptt. Is also responsible for process validation, preparation of various documents related to manufacture and quality control and calibration of various equipment.

Release of finally tested product takes place in the following way:

1. As soon as the product is finally tested, analyst prepares the analytical report as per Quality Control Monograph.
2. Product, which is passing in all respects, is approved.
3. Analyst signs the report with date.
4. Quality Assurance Manager signs the report or authorizes an approved analyst to sign on his behalf.
5. Analyst affix Quality Approved Stamp assures that these are fixed on the individual container.
6. Attach copy of the analytical report together with in-process controls to the Master Batch Record.
7. Analyst signs the Master Batch Record with the date of completion of analysis.  Quality Assurance Manager finally signs the Master Batch Record and keeps it in safe custody.
8. Prior to packaging of the product, production supervisor requests for the Master Batch record along with Packaging portion of the Master Batch Record.
9. In case, the product is not passing as per Quality Control Monograph, the production is rejected and the matter is investigated along with Production Manager.  Results of investigation are intimated to Production Director for further action.

 

CONTRACT MANUFACTURE AND ANALYSIS:

DESCRIPTION OF THE WAY IN WHICH THE GMP COMPLIANCE OF THE CONTRACT ACCEPTER IS ASSESSED:

The organization has no such type of contract activity so far in manufacturing currently

For analysis, Samples of products / materials sent to approved testing laboratories by Q.C. Deptt., for which the facilities are not available and such contract analysis is co-ordinated by the Q.C. Deptt. Only.  The facilities, equipment’s, protocols etc. required for such tests are first inspected, checked by Q.C. head to satisfy himself and then only the samples for such tests provided.  In this case the product/material is released only after receiving the part analysis report also from approved testing labs and the reference of such test, report no. etc. be provided in the final test report of the material/products.

DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL:

ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION.

The organization will operate the distribution system direct from factory.  Store person feed the orders in computer so that they get an invoice with batch no. etc.  It works on FIFO (first in first out basis) for product as well as orders.  Invoice is checked by store in-charge for goods stock position (if required to make cartons & strap them etc.) then send to the dispatch Dept.   Copy of invoice is sent to the head office for further action.  A record of distribution of final product of particular batch is maintained in kept in the B.P.R.

ARRANGEMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALL.

Stock of product, which may be returned to stores for any reason, should be accounted for and dealt in consultation with Q.A. Manager.

Returned goods must be isolated on receipt, clearly identified and recorded indicating the details of the consignment and the reasons for return.

The Q.A. Manager should promptly examine the returned goods to determine whether such goods should be reprocessed or destroyed or even released for distribution.

Further disposal of examined goods should be authorised by the Quality Control Manager.  If destruction of the goods has been recommended, this should be done under supervision, of Q.A. Manager and details of such destruction must be recorded.

Reprocessing of returned goods should be done in accordance with the instructions given by the Q.A. Manager.

In case of reprocessing, re-distribution of returned materials, information for such returned should be sent to Central Excise Deptt also.

PRODUCT RECALL

All the product complaints are to be dealt according to SOP.

If the action requires a product withdrawal completely or partially the Q.A. Manager should inform the General Manager / Director regarding the results of the investigation and advise to recall the product or a particular batch completely or partially with the approval of the above.

Q.A. Manager should withdraw the Bin card of that particular batch/es of the product from F.G. store and issue necessary instruction to sales distribution to recall the above batch/es of the product from the market.

On recalling Q.A. Manager should ensure that all the materials that are recalled are accounted for.

As soon as the complete stock is reconciled, the Q.A. Manager should initiate necessary action to rework or destroy the stocks in consultation with the General Manager / Director.

The destruction of the recalled batch/es should be carried out in the presence of Q.A. Manager and the Production Manager.

SELF-INSPECTION:

SHORT DESCRIPTION OF THE SELF-INSPECTION SYSTEM:

OBJECTIVE:

Self inspection is an independent review and evaluation of entire manufacturing operations which cover Current Goods Manufacturing Practices (CGMP’s) adopted during manufacturing, testing and packing operations of the plant.  It also verifies the effectiveness of Quality Assurance Programme and its compliance with the regulatory affairs.  This programme will provide:

1. Overall view of the operational strengths and weaknesses.
2. Opportunity to correct the defects in the system.
3. Assure product Quality.

 

FREQUENCY OF SELF INSPECTION:

a)         Self inspection is conducted twice in an year by plant personnel from Production, Quality Control and Management.

 

INSPECTION TEAM:

Self Inspection:

Two or more experts from plant consisting of manufacturing experts and Q.A. experts conduct self-Inspection.

SCOPE OF SELF INSPECTION:

The Self Inspection serves the purpose of confirming to the top management of the company that the operations are being performed as per the guidelines issued.  It also gives the scope that the defects pointed out and remedial steps suggested are to be completed in a time bound programme.

INSPECTION PROGRAMME:

The inspection is to be carried out as per a defined programme and schedule.

Identify areas and systems to be inspected and should be completed as per the time bound schedule.

TECHNIQUES OF SELF INSPECTION:

In self-inspection one is critically examining the activities of a department by interviewing and try to gather as much information as possible through their co-operation.  Compare the master batch record with the original product file.  Examine the records, documents, procedures etc.  Check them for the adherence to SOP’s.   All critical and major defects should be immediately investigated and action plan with time bound schedule is to be finalized.  Compliment any good points observed.  Discuss the points observed in the section and come to an agreed action plan with time bound for any critical, major or minor points observed during inspection.

 

WHAT TO BE SELF INSPECTED:

Self-Inspection will cover all line and support observations and departments that directly or indirectly affect the quality of the product.

1. Line operations: Ware housing, dispensing, manufacturing, packaging and distribution.
2. Support functions: Quality control and assurance, vendor development, engineering.
3. Vendors, contract manufacturing.
4. Key systems in all departments.

 

The above points are elaborated as follows:
a)         Spend 30% of the total inspection time physically inspecting the facilities, manufacturing operations, support systems etc.
b)         Balance 70% of the time should be spent to check the adequacy of cleaning, calibrating and conditions of the equipment’s used for manufacturing.
c)         Choose a process or procedure of manufacturing, challenge its completeness, verify the entire process and check the degree of adherence.
d)         Pick up any product and check the entire system i.e. from raw material receipt, test reports, manufacturing procedure, SOP’s, packaging, distribution, etc.  Critically examine all the records, log books, test reports, raw data to trace a product from raw material to distribution stage.
e)         Check the out put of process for average yield.
f)          Check the physical appearance of the products from the finished packs.

SELF INSPECTION REPORT:

At the conclusion of the self-inspection a comprehensive report should be prepared within 10 days giving the self-inspection finding and corrective actions required and should be submitted to the management.  Any defect observed should be classified as critical, major, minor and also record if possible the root cause.  Agreed action plan with time bound schedule should also be included in the report.

SELF INSPECTION COMPLIANCE AND FOLLOW UP:

The defects or deficiencies should be reviewed as per the action plan and compliance report should be submitted to the management.  This report should form the basis of the next inspection.

Examples of critical, major and minor deficiencies:
Critical, defects:

 

1. Cross contamination of raw materials during storage.
2. Product manufactured without batch record or in-process data or unauthorized changes.
3. Product mix-ups.
4. Incorrect labels.
5. Results out of specifications, but still released.
6. Product released without Q.C. approval.

 

Major defects:

 

1. Rejected materials not segregated.
2. Balances not calibrated.
3. No SOP for equipment, operation cleaning etc. not recorded.
4. Batch processes not documented as per shape.
5. Analytical data or raw data not available.
6. Reference Standards, normality’s not available from raw data.
7. Process, Weight variation usually going out of specification but still manufacturing is going on.

 

Minor defects:

• Areas not cleaned regularly.
• Approved/released stickers missing in containers.
• Cleaning SOP not signed.
• Temperature not recorded in products.

 

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