sop for vendor approval of raw materials
1.0 OBJECTIVE: :
1.1 The objective of this SOP is:
1.1.1. To describe a procedure to assess the vendors who can manufacture and supply materials of consistent quality and quantity and at right time
2.0 RESPONSIBILITY:
2.1 The Head – Quality Assurance shall be:
2.1.1. Responsible for auditing the vendor for cGMP Compliance periodically in co-ordination with Head – Materials.
2.1.2. Responsible for preparing the vendor audit report and further necessary actions.
3.0 ACCOUNTABILITY
Head – Technical Operations
4.0 PROCEDURE:
4.1 Methodology:
4.1.1 All existing Vendors who have already been approved by our (Mother Plant) and Research & Development shall continue as Approved Vendor.
4.1.2 Head – Materials shall be responsible for initiating the need for New vendors.
4.1.3 New Vendors shall be assessed for their technical capabilities by Quality Assurance and Materials Department
4.1.4 Head – Quality Assurance shall recommend approval of a New Vendor based on their overall technical capabilities and quality management system which can be accessed by Vendor audit for GMP compliances & documented as per the check list as per Annexure – 1.
4.1.5 Head – Materials shall be responsible to negotiate on commercial aspects viz. delivery schedule, packing, price etc.
4.1.6 The over all coordination of the activity shall be performed by Head – Technical Operations and Head – Materials and he shall be responsible for approval of New Vendor on their overall technical capabilities and financial conditions.
4.1.7 The current vendor shall continue to remain approved, on the basis of their past performance, and re-approval and is if shall be done once in 2 year to continue as approved vendor for API as well as Raw Material.
4.1.8 The Head Quality Assurance or Head –Technical Operations and Head – Materials shall audit the facility of the concerned vendor and shall record all information given in checklist for ready reference as per Annexure – 1.
4.1.9 Irrespective of any amount of urgency, receipt of duly filled checklist and its review will be emphasized before placing the trial order for new vendor.
4.1.10 All the specifications of materials shall be provided to vendor / supplier by the purchase officer of materials department.
4.1.11 Commercial negotiations shall be organized by Head – Materials in co-ordination with Head – Technical Operations
4.2 Assessment of the pre-purchase samples:
4.2.1 Based on the agreed specification and technical discussion, the vendor shall arrange to forward pre-purchase samples of 3 independent batches to materials department along with their certificates of analysis.
4.2.2 Materials Department shall send the Pre-purchased sample to Research & Development (R&D) along with Certificate of Analysis for complete evaluation.
4.2.3 R & D shall analyse the sample as per specification, if any clarification is needed, then may contact the vendor for Standard Test procedure or Working Standard etc.
4.2.4 Sample performance shall be finally evaluated by Head – R&D, based on the COA. In specific situation, such as suitability through stability evaluation or trial is foreseen the, the approval of vendor shall await, till the same is completed.
4.2.5 R&D shall convey the finding to location Quality Assurance Head and Head – Technical Operations on the basis, which Quality Assurance shall plan and carry out vendor audit to confirm the compliance level of cGMP at vendor audit report and data submitted by R & D.
4.2.6 Head – Quality Assurance or Head – Technical Operations and Head – Materials shall conduct the cGMP Audit.
4.2.7 After Audit, audit report shall be forwarded to Head – Technical Operations.
4.2.8 Head – Technical Operations shall take the decision for approval or rejection of the basis of vendor audit report and data submitted by R & D.
4.2.9 If the vendor is approved, the vendor list shall be updated and the Master Copy shall be remained with Quality Assurance, and Certified copy shall be issued to Warehouse, Materials and R&D.
4.2.10 During annual product review if any adverse observation was detected due to any of the raw materials then the vendor shall be identified and his approval is canceled. The vendor is then enrolled as Black listed Vendor.
4.2.11 Annual Plan for Vendor Audit shall be prepared in advance and inspection shall be done accordingly.
4.2.12 Approved vendor shall be re-evaluated for compliance of cGMP with in 2 year of approval or earlier base on the trend of rejections for a particular vendor.
5.0 REASON FOR REVISION:
This SOP is revised in order to be more effective in Vendor approval procedure.
6.0 Training:
Trainer — Head – Technical Operations
Trainee — All Departmental Heads
Period — One day
7.0 DISTRIBUTION:
Certified Copy No. 1 – Head Of Department Quality control
Certified Copy No. 2 – Head Of Department – Materials
Certified Copy No. 3 – Head Of Department – Purchase
Certified Copy No. 4 – Head – Plant Operations
Reference Copy No. 5 – File Copy in Vendor Approval File
Original Copy – QUALITY ASSURANCE
8.0 ANNEXURES:
Annexure – 1 : Vendor Audit Questionnaire.
9.0 REFERENCE:
In-house
ANNEXURE – 1
CHECKLIST OF QUALITY EVALUATION OF THE VENDOR
NAME OF THE VENDOR : ——————————————————————
LOCATION OF THE PLANT: ——————————————————————
PRODUCTS OFFERED : ——————————————————————
A. ORGANISATION
ORGANOGRAM
| Plant | Yes/No |
| QA/QC | Yes/No |
| CONTACTED PERSON DURING VISIT | |
| Managing Director/ Technical Director | Yes/No |
| Site in charge/Plant Manager | Yes/No |
| QA Manager/ QC Manager | Yes/No |
| Production/ Packaging Manager | Yes/No |
Sales Manager |
Yes/No |
B. FACILITIES
| Plant layout | Acceptable / Not acceptable |
| Maintenance of the Premises | Acceptable / Not acceptable |
| General house keeping | Acceptable / Not acceptable |
| Scope for expansion | Yes/No |
| Plant Life | 0-5, 5-10, > 10Years |
| Is the Facility dedicated | Yes/No |
| Is the Manufacturing area is adequately Ventilated | Yes/No |
| Is the separate area for sampling of Raw Material Available | Yes/No |
| Is the manufacturing/ Packing area provided with adequate light | Yes/No |
| Are area available for Sterility (for sterile Preparations) intermediates and finished products | Yes/No |
| Are balances and measuring equipment’s of the appropriate range available | Yes/No |
| Are fixed pipe works labeled to indicate the Contents and directive for flow | Yes/No |
| Is pest and rodent Control program is available | Yes/No |
Rating
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- QUALITY ASSURANCE SYSTEM
| Do they have approved specification | Yes/No |
Do they have approved STPs |
Yes/No |
| Do they have approved SOPs | Yes/No |
| Do they have stability Programs | Yes/No |
| Do they have formal training programs For Production and QA |
Yes/No |
| Do they have written schedule for training | Yes/No |
| Do they have written calibration schedule of the analytical instruments |
Yes/No |
| Do they have quality Assurance system for the supplier |
Yes/No |
| Do they have standard sampling plan | Yes/No |
| Do they have proper storage facility | Yes/No |
Do they have proper system to check inputs |
Yes/No |
| Do they received material with certificate of analysis | Yes/No |
Do they posses adequate testing facility |
Yes/No |
Do they have competent and adequate staff |
Yes/No |
Is corrective action taken for defect identification |
Yes/No |
| Does an authorized manufacturing formula exist | Yes/No |
| Are processing instruction provided in details | Yes/No |
| Is a batch processing record available for each batch processed |
Yes/No |
| Are dates and times are recorded for various stage of operation |
Yes/No |
| Are critical steps are cross verified | Yes/No |
Rating
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- MATERIAL CONTROL
| Are Released/Rejected/ Under test materials segregated properly | Yes/No |
| Is rejected material controlled adequately destruction in case of PMS – printed material |
Yes/No |
| Are Material handled properly to prevent damages | Yes/No |
| Do they have secured, lockable facilities to control narcotic drugs and labels |
Yes/No |
| Are Material properly segregated to prevent mix-ups | Yes/No |
| Do all the containers have the proper label for product, batch no. Qty, Mfg, Exp, Date etc. |
Yes/No |
| Are receiving procedure adequate | Yes/No |
| Are adequate facilities available to store the material at their premises |
Yes/No |
| Ware house of Incoming material | Adequate/ Inadequate |
| Ware house of outgoing material | Adequate/ Inadequate |
| Insurance facilities | Adequate/ Inadequate |
| Transport facilities for receiving materials | Adequate/ Inadequate |
| Transport facilities for dispatching materials | Adequate/ Inadequate |
Rating
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
E. MANUFACTURING/ PACKAGING
| Are manufacturing process adequate to produce quality components (written/ Approved document) | Yes/No |
| Are line clearance concept adopted at the time of change over of product to prevent batch mix-ups/ Product mix – ups |
Yes/No |
| Do the personnel in manufacturing have the awareness towards the quality |
Yes/No |
| Do production personnel follow the working disciplines as per c GMP requirements (Head gear, Safety goggles, Hand gloves, Nose masks ets.) |
Yes/No |
| Are waste material kept separately in proper container | Yes/No |
| Are equipment’s maintained/calibrated as per schedule | Yes/No |
Are in process checks adequate to ensure consistency in quality |
Yes/No |
| Are proper accountability done after completion of the batch |
Yes/No |
| Are adequate precaution exercised during packging to prevent mix-ups |
Yes/No |
| Are excess coded packaging material (labels/ Cartons etc.) destroyed after completion of the batch |
Yes/No |
| Are documentation adequate during manufacturing and packaging to ensure the Quality |
Yes/No |
| In handling of material and product performed in accordance with written procedures |
Yes/No |
Are all manufacturing process clearly defined |
Yes/No |
Whether systems exists for process/product/equipment status indication system |
Yes/No |
Are there any checks on yields to ensure that they are not out side acceptable limits |
Yes/No |
Are air locks or air extraction system provided to avoid contamination in necessary |
Yes/No |
RATING
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- RELIABILITY/ CUSTOMER SATISFACTION
| Is there formal system to investigate rejection/ market complaints |
Yes/No |
| Is there proper system to report failures | Yes/No |
| Is there formal system to provide feed back to customers |
Yes/No |
| Is there any list of other customer’s available | Yes/No |
| Does vendor complete entire work or take the help of sub – contractor |
Yes/No |
| Are they capable to adhere delivery schedule | Yes/No |
| Do they have proper record on feed back on quality of their product from other customers |
Yes/No |
RATING
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- FINANCIAL RANKING (CREDIBILITY IN MARKET)
What is the approximate value of inventory held Rs. _________
What are the major items for which inventory held Class A____%, B______%
What is approximate annual turnover of sales Rs. _________.
Study of financial terms:
- Documents against acceptance
- L/c sight or clean credit
- Documents through bank
- Performa Purchase
- Co-acceptance scheme
- Direct suppliers
Is he open if we approach his bankers to check his financial rating |
Yes/No |
| What is the last year approximate gross profit | Rs._____
|
| Any future plans for expansion / diversification |
Yes/No |
RATING
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- COMMERCIAL OBSERVATIONS
Does he prefer long term contract? Order backed supplies
Does he prefer delivery FOR Sight /Works
Discount structure
Can he supply through DAMAN/ TAX/ TAX FREE ZONE
| I. RECORDS KEEPING | Adequate/ Inadequate |
| J. COMPUTERISATION | Adequate/ Inadequate/Nil |
K. SCRAP DISPOSAL PROCEDURE |
Adequate/ Inadequate |
| L. LABOUR MANAGEMENT RELATION | Adequate/ Inadequate |
| M. GENERAL OBSERVATIONS | |
| How would you rate the morale of the total Organization | Poor/ High/ Very high |
| How would you rate the progressiveness and competence of supplier’s management | Poor/ High/ Very high |
| How would you rate the technical capability of the vendor | Poor/ High/ Very high |
| How would you rate the financial capability of the supplier | Poor/ High/ Very high |
| How would you rate the commitment to Quality/ performance of the material from supplier | Poor/ High/ Very high |
| How would you rate the commitment to timely delivery of the material from supplier | Poor/ High/ Very high |
RATING
| 1 | 2 | 3 | 4 | 5 |
( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)
- CONCLUSION
Remarks : ________________________________________________________________________________________________________________________________________________________________________________________________
| Date | SIGNATURE : |
| DESIGNATION: |