Vendor Qualification and Management

1.0	PURPOSE To lay down a procedure to ensure the suitability of vendor for supplying material for pharmaceutical products manufactured by Company Name.
2.0	SCOPE Introduction of a new Vendor (manufacturer & supplier), preliminary assessment through Questionnaire, Assessment of the pre-shipment samples, vendor buyer formal meeting for technical co-ordination (optional), Annual Calendar-vendor audit programme, Vendor’s Quality System Audit, Production Performance, Reporting and follow up system and final Approval / Rejection. The procedure shall be applicable for the starting material required for Bulk Pharmaceutical Chemical, Drug Products and Packaging materials at XXXs India Limited, Haridwar.
3.0 3.1 3.1.1 3.1.2 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 3.3.3	RESPONSIBILITY Quality Control Head: Preparation of Standard Test Specification of required materials and packaging components. Conduct analysis on purchase sample and provide COA to head QA. Purchase Incharge: Identifies potential Manufacturer/Suppliers. Obtains sample from Vendor for analysis against the specifications provided by Quality Assurance. Quality Assurance Head: Review results from Purchase sample submitted by Purchase Department. Review questionnaire completed by vendor assuring that internal controls and any appropriate analytical services are adequate to provide materials that shall continually meets approved Test Specifications. Approves or rejects the vendor.
4.0	ACCOUNTABILITY Head Of Department (Purchase, Quality Control) and Quality Assurance head.
5.0	PROCEDURE
5.1 5.1.1 5.1.2. 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9 5.2 5.2.1 5.2.2 5.2.3 5.2.6 5.3 5.3.1 5.3.1.1 5.3.1.2 5.3.1.3 5.3.1.4 5.3.2 5.3.2.1 5.3.2.2 5.3.2.3 5.3.2.4 5.3.2.5 5.3.2.6 5.3.2.7 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3	Vendor Approval System : The current vendor shall continue to remain Approved, on the basis of their past performance, unless the need arises for their re-appraisal. In all cases the background information of the vendor (actual manufacturer in this case) and their Quality systems shall be obtained through a Questionnaire (Annexure – I) irrespective of their being current, new domestic or foreign supplier. The Questionnaires shall be reviewed and updated periodically to collect information on Vendor’s Quality Systems, General background, and Organizational structure. Irrespective of any amount of urgency, receipt of consent letter and duly filled questionnaire and its review will be emphasized, before placing the trial order. Duly completed questionnaire received from all the vendors shall be reviewed by Purchase Department and Quality Assurance Department. A meeting of the technical personnel from both the sides shall be organized, for the preliminary assessment of their capabilities either at XXXs or during vendor visit. To manufacture and supply material of required quantity and consistent quality complying XXX’s In-House specification at all time. Any other additional information or technical co-ordination as may be required on either side. Forward the vendor selection questionnaires to all vendors as identified above and get feed back within 15 working days and send same to the Head Quality Assurance. Development of a new vendor : A need for the entry of a new vendor shall be critically evaluated, as the formalities of development and approval of new vendor involves lot of resources of the company. In case a need arises for any new vendor, either because of :                    a)A new product launch                    b)An alternate source identified by purchase department                    c)On the supplier’s request to enter in business with XXX                    d)Existing vendor with additional item                    e)An offer with substantial saving without quality compromise in the business                    f)Present vendor rating not satisfactory                    g)Any other reason VENDER RATING DEFINITION: Rating Definition Grade 1 Vender fall into this category which have no quality Issue i.e. zero defects. Grade 2 Vender fall into this category which have received complain but not related to quality of the product. Grade 3 Vender fall into this category which have received complain with quality issue but not major impact on product quality. Grade 4 Vender fall into this category which have not a standard of product quality. . Their channel for communication and entry shall be only through Purchase Department. Approval of a new vendor : Preliminary Assessment : Subject to the critical evaluation of the need, for a new vendor (agreed) background information shall be obtained through the questionnaire as per annexure I. The duly completed questionnaire received as referred to shall be reviewed as mentioned in 5.1.5 A formal meeting of the technical personnel from both the sides shall be organized  and conducted as expressed in 5.1.3 and 5.1.6 Subject to the satisfactory negotiations and agreed terms, a copy of the XXX’s in-house specifications shall be issued to the vendor, for the requirement of the pre-shipment samples. Assessment of the Pre-shipment samples : Based on the agreed specification and technical discussion, the vendor shall arrange to forward pre-shipment samples (3 incase of domestic vendors & minimum one for overseas vendor) of independent batches to purchase department along with their certificates of analysis complying XXX’s specifications. [Applicable to domestic vendor while the requirement shall be assessed case by case for imported item.] The pre-shipment samples shall be entertained only if, they are accompanied with following documents : a) An official document duly signed by concerned Manager b) Consent on XXX’s specification c) Certificates of analysis complying XXX’s specifications. d) A duly filled and completed questionnaire. The samples shall not be entertained, in case, if they are not accompanied with any one of the above referred documents. After issuance of all the specifications, method of analysis, sampling requirements etc. All the pre-shipment samples / trial order consignment must conform to the XXX’s specification and no replacement shall be entertained. Incase the Purchase Department still wants their pre-shipment samples / trial order consignment failures. The sample after it’s inspection by QC shall be routed to Production Department (optional) along with duly filled New Vendor Approval form and Certificates of analysis received from the vendor and our in-house test report. New Vendor recommended by production after taking satisfactory trial for the new product launch, COA of QC analysis considered and while rest of the formalities shall remain unchanged. The questionnaire, consent on specification and sample performance shall be finally evaluated by QA, based on the COA. In specific situation, such as suitability through stability evaluation or trial is foreseen, the approval of vendor shall await, till the same is completed and same will be informed to Commercial Department. Vendor Audit : Based on the review of the questionnaire, technical discussions, analytical findings of the pre-shipment sample and the criticality of the item, QA shall indicates need for vendor’s plant audit (if required). In case the same is not required, QA may as well as recommend Approval / Rejection of the vendor as appropriate. Purchase Department / Concerned head shall organize the plant visit at an early date mutually agreeable at both the ends, but preferably within a week time. Vendor’s Quality Systems’ audit shall be performed by a representative from QA preferably accompanied by a commercial representative during the audit visit. Representatives from Production and QC shall be invited, need based. QA representative shall lead the audit activity and shall briefly summarize the observations and findings of the audit, to the organizational Incharge during post audit discussions. QA shall submit vendor visit report and give final comments on overall technical capabilities of the Vendor with a recommendation for Approval or rejection of the “New Vendor”. The approval shall pertain to the specific manufacturing site, which have been assessed subsequent changes will require additional “Approval” from XXX. Purchase Dept. shall give their final comment on commercial aspect and take approval from Technical Director. or as appropriate. Technical director shall approve or reject the vendor on overall assessment of “Techno-Commercial” aspects. Intimation of addition / deletion of a vendor : QA shall intimate concerned location plant / Production In-Charge, purchase and Stores In-Charge of any addition of a new vendor or deletion of a vendor through addendum. At this stage the vendor is considered as “APPROVED” for the item / category of items. Head Purchase shall now organize and initiate procurement of material from these approved vendors on regular basis. Existing Vender qualification: QA Deptt shall intimate to store deptt. to arrange 3 batch of raw material sample for evaluation of existing Vender. These samples are handover to QC Deptt. for Analysis as per raw material specification. QC Deptt. analyzed the sample & results are submitted to QA Deptt. for Review of Quality data. On the basis of raw material testing data, QA Head Shall take decision for approval/rejection of vender and record the details as per Annexure II.
6.0	REFERENCES                                                                                                                                                                               Not Applicable

7.0	ANNEXURES
Annexure No.		Title of Annexure	Format No.
Annexure-I		SUPPLIER / MANUFACTURER QUESTIONNAIRE	QA/023/F01-03
Annexure II		ExISTING VENDER QUALIFICATION	QA/023/F02-01

8.0	ABBREVIATIONS

Abbreviations	Full Forms
SOP	Standard Operating Procedure
XXX	Company name
No.	Number
QA	Quality Assurance
COA	Certificate of Analysis

 9.0    DISTRIBUTION

Master Copy					Quality Assurance Department
Controlled Office Copy No. 1					Head Quality Assurance
Controlled Office Copy No. 2					Head Quality Control
Controlled Office Copy No. 3					Head Purchase
10.0	REVISION HISTORY
S.No.		Revision No.	Effective Date	Reason for Revision		Details of Change	Authorized By (sign & Date)

                                                      ANNEXURE-I 

                      SUPPLIER / MANUFACTURER QUESTIONNAIRE

NAME OF THE VENDOR:

LOCATION:

1.0     Questionnaire:

This questionnaire is intended to obtain information, which we feel is essential to our evaluation of the continuing quality of the product (s) we purchase from you. Since no reasonable amount of testing will tell us as you can about the manufacture and control of your products, we request that you fill out this questionnaire as completely as possible. This information along with our inspecting and testing of the incoming material will be of assistance in making valid quality judgments.

Since this questionnaire is designed to be used with a variety of suppliers covering various types of raw materials that have a number of ultimate uses, we recognize that there are questions, which may not always be applicable. If this is the case, an indication of “Not Applicable” will suffice.

It is recognized that some of the information we seek is privileged and we will treat it accordingly.

Your co-operation in completing this questionnaire as accurately as possible will very much appreciated. If you desire further clarification regarding a section of it, please feel free to contact us.

2.0                       GENERAL

2.1            Year of Establishment……………………..             

2.2           Present Annual Turnover……………………………………………………….

2.3            Business activities (i.e. product mfd. /dealt in)…………………………………………

2.4           Constitution of the Firm (Proprietary / Partnership / Director / Partner / ………………

2.5           Name of the Proprietors / Partners / Directors

2.6           Sales Tax No……………………… Central Sales Tax No…………………………..

2.7            Banker’s Name & Address    ………………………………………………………….

                                                                …………………………………………………………

                                                                …………………………………………………………

2.8            Product Proposed To Be Supplied To XXXs…………………………………

2.9            List of Potential Customers……………………………………………………………...

2.10          Office Address:               ………………………………………………………………

                                                        ……………………………………………………………...

                 Contact Person …………………………….          Telephone. No. …………………..

         Out of Hours (Tel. No.)…………………………………………………………………

2.11          Sites of Manufacture…………………………………………………………………….

                 (Address)             ……………………………………………………………………….

                                        ………………………………………………………………………..

                 Contact Person …………………………….          Telephone. No. …………………..

         Out of Hours (Tel. No.)…………………………………………………………………

2.12          Drug license no. (If applicable) ……………………………………………………………

2.13          No. of personnel employed ………………………………………………………………..

2.14          Name & Status of the Production In-Charge ………………………………………………

                 Responsible To …………………………………………………………………………….

2.15           Name & Status of the Quality In-Charge ………………………………………………

                  Responsible To …………………………………………………………………………….

          2.16                                                List Certificate / Registration Obtained ………………………………………………...

                   E.g. WHO-GMP, MHRA, MCC, TGA, USFDA, ISO etc ………………………………………

3.0                                   MANUFACTURING PROCESS

      The following information is required to ensure that the tests and standards in      

      XXXs specification are pertinent to your method of manufacture, that our   

      sampling plan is adequate, that impurities peculiar to the process might be controlled,

      and to assure that cross-contamination will not occur.

                                                                Yes                         No             N/A             Comments

3.1        Do you have a formalized system for

 Receipt, storage and handling of raw 

 materials?

3.2        Do You Analyze Raw Materials?

3.3        Are materials segregated or status labeled prior to use. ?

Does any material require special storage condition? If so, state 

3.4         Are samples of starting materials    retained?

3.5        Do batch records specify amount of

Material to be used?

3.6        Do batch records specify lot number of material used?

3.7        Are batch records checked and signed? If so, specify by whom?

3.8        Do batch records specify which machine / equipment are used?

3.9        Are critical process operations, identified and validated?

3.10      are any operations carried out in a

Controlled area e.g. clean room? If so,

Specify.

3.11      are any operations carried out off the site? If yes, please specify the details of arrangements and controls.

3.12      At start up, are checks carried out?

If so, specify.

3.13      are in-process checks carried out?

If so, who is responsible for carrying out in-process controls? And specify frequency.

3.14      Is reconciliation carried out at end of batch?

3.15      Are process equipment cleaned and checked on a regular basis? If yes, please specify?

3.16      Are materials passed for release or

Quarantined immediately after manufacture?

3.17      If material is quarantined, is this held in a specific area?

3.18      Are other products manufactured in the same area? If so, what steps are taken to prevent cross-contamination?

3.19      are common equipment used for this and other products in any stage of process? If yes, have you established cleaning validation data?

3.20      What raw materials do you use for this process and what specifications do they

Comply with i.e. pharmaceutical or in-house.?

4.0        Please provide an outline of the process

(Attach separate sheet) involved and the process controls exercised to prevent contamination and achieve consistent quality product meeting XXX’s specification.

4.1        Is this material made by a batch process or by a continuous process?

                            

4.2        If you are the manufacturer will you inform XXXs, prior to shipping, for changes such as?

A.          You change you method of     manufacture significantly; for example one that might introduce impurities in the product?

                                        

B.     The location of the plant is          changed?

                

C.    your regular sources of raw materials are charged?

5.0        Lot or batch identification (packed product)

It is a requirement of our company that we be able to trace our product history back to our

Purchased raw materials.

Can your company offer full trace ability from raw materials to finish goods?

     ————————————————————————————————————

     ————————————————————————————————————                                                     

5.1        To what quantity or description of material do you assign a given lot number?

     ————————————————————————————————————

      ————————————————————————————————————

5.2        What does a typical lot number look like and how can we recognize it as a lot number?

      What is the significance of each element in the lot number?

     ————————————————————————————————————

      ————————————————————————————————————

5.3        What is the typical lot size?

     ————————————————————————————————————

      ————————————————————————————————————

5.4        Do you agree to supply?

XXXs in the biggest lot size

Available and at minimum

Frequency

5.5        Is the material identified

     with one lot or batch number

     homogeneous, both physically

     and chemically thus making a

random sample withdrawn from

one of the containers, representative

of all the containers in the lot.

6.0        SPECIFICATIONS, DOCUMENT & RECORDS

6.1         Specifications

6.1.1     To What Specifications, Standards, Compendia, Etc Does Your Product Comply?

     ————————————————————————————————————                      __________________________________________________________________________

6.1.2      What do you feel are likely by products or impurities inherent to your process that

              could be present in this product. (See also 6.1.5)

     ————————————————————————————————————__________________________________________________________________________

6.1.3      Please attach a copy of your specifications. Also include specifications for different

 grades of the same material available from you. (See also 6.1.6)

      ————————————————————————————————————___________________________________________________________________________

6.1.4      Can you provide us with a written assurance, that your product meets the limits set

 out in table 1 of the organic volatile impurities test detailed in current USP?

     I.e.  Organic Volatile Impurities Limit (mcg) Properties                                    Yes   No   N/A  

    1. Benzene                              2                  Carcinogen

    2. Chloroform                        4                  Toxic & Environmental Hazards

    3. 1,2 Dichloroethane                         5                  Toxic

    4. 1,1 Dichloroethane                         8                  Toxic

    5. 1, 1,1Trichloro Ethelene      1500               Environmental Hazard

6.1.5     (Active Raw Materials Only)

Does your product comply with the following specifications for toxic solvents and relatively non-toxic solvents?  Please provide written details, or written assurance   that these solvents are not used in manufacture:

Toxic solvents not covered in USP                                              NMT 0.1%

       (Methanol, hydrocarbons, toluene etc)

Relatively non – toxic solvents                

      (Ethanol, isopropanol etc.)                                                        NMT 0.2%

6.1.6      (Active Raw Materials Only)

 Please provide details of your particle size specifications and the test method used.

6.1.7      Please provide your suggestion as to how the XXX’s specifications might be improved so that we can maintain a realistic meaningful and adequate document, which might better describe your product and not be unduly restrictive.

6.2        DOCUMENT

                                                                 Yes                    No                   N/A      Comments

6.2.1     Does a formally controlled quality

system exist?

6.2.2     Does SOP(s) exist for?

a           Stores

b           Equipment

c           Production Operations

d          QC Operations

e           Engineering

f           House keeping, sanitation &

              personal hygiene

6.2.3     Are master documents issued and

 approved before use

If so, who is responsible for approval?

6.2.4     Are certificates of analysis or certificates

of conformance issued against batch of

material produced?

6.3.       RECORDS

6.3.1     Does your company carry out self –

Inspection and record findings?

6.3.2     Are production operations recorded on

batch documentation or other systems?

6.3.3     Are documents field and retained?

If so, for how long?

6.3.4     Are calibration records maintained?

6.3.5     Does your company carry out vendor

assessment ? Are records maintained?

6.3.6     Does your company conduct GMP

training and maintain training records

for:

a            Operations

b            Supervisors

c            QC Staff

7.0        QUALITY CONTROL PROCEDURES

                                                                           Yes              No          N/A            Comments

7.1        Are Finished Goods Sampled And Tested?

7.2        What Sampling Plans Are Used?

7.3        Are all test methods fully documented &

controlled?

7.4        State, if applicable, what

equipment is used for testing

and if calibration and maintenance

records are available.

7.5        If any off site testing carried out?

If so, please specify.

7.6        Are samples of finished goods retained?

If so, specify for how long.

7.7        Is any assessment of product carried out

before dispatch?

7.8        Do You Handle Other Materials On Site?

7.9        Do you have a preferred transport carrier?

If yes, specify.

7.10      Are Distribution Records Kept?

7.11      Does your company have a system

for disposal of returned or rejected

materials?

7.12      Does your company have a complaint

procedure?

7.14      Has your company been assessed by

other companies?

If so, what were the findings?

8.0        QUALITY ASSURANCE

The following is needed to tell us more about your system of control which assures that your product conforms precisely to specifications and how you document the quality history of each batch so that, we can design our statistical examination of your material more meaningfully.

8.1        What Tests Do You Routinely Run On Each Batch Or Lot of Material?

      _____________________________________________________________

_________________________________________________________________________________________________________________________________

8.2        Are your methods for testing the same as those referred to in the

XXX’s specifications?                                           Yes                              No

If not, please indicate where and how they differ.

      _____________________________________________________________

________________________________________________________________________________________________________________________________

8.3        Will you notify XXXs if and when your testing

 procedure is changed significantly?                                       Yes                         No

8.4        Do you maintain records of the tests you perform?

If so, may we obtain this data upon request?

8.5        could you provide a certificate of analysis for each

lot or batch?

8.6        Would such certificate actually reflect an analysis

on the particular lot?

8.7        What Are Your Storage Recommendations?

8.8        How long should this product be stable under

recommended storage conditions?

     

QUESTIONNAIRE COMPLETED BY ——————————

SIGNATURE ———————————— Date ——————

POSITION —————————————

Annexure II

EXISTING VENDER QUALIFICATION

NAME OF MATERIAL: - ____________________

NAME OF VENDER & ADDRESS: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

BATCH NO.1:- ______________                   A.R.NO.:-____________________

BATCH NO.2:- ______________                   A.R.NO.:-____________________

BATCH NO.3:- ______________                   A.R.NO.:-____________________

v  The Analytical data review of three consecutive batches of said material found with in specified limit.

v  Conclusion: - On the basis of analytical data review and consistency found in material quality. The vender of said material is approved.

	PREPARED BY	CHECKED BY	APPROVED BY	AUTHORIZED BY
SIGN
DATE