sop for vendor selection and Evaluation
1.1 The main objective of a pharmaceutical plant is to produce finished products for the patients’ use from a combination of materials. The quality, timely delivery and cost of incoming materials are the critical aspects that will affect the final product. So special attention is to be paid to knowledge of the supplier’s quality assurance system, in assessing the suitability of a source. This Standard Operating Procedure describes the evaluation process to ensure the adequacy of the vendor’s manufacturing facility for producing materials as per our standards / specification.
2.1 This SOP is applicable for initial vendor pre purchased sample test and trail, vendor visit / audit and final approval / non-approval state of the vendor for material to be supplied (from India or abroad) for manufacturing
3.1 Asst. Officer or above – Quality assurance – Prepare the SOP and follow-up the SOP accordingly
3.2 Asst. Manager – Quality Assurance-Provide the support to the implementation of SOP and maintained the records.
4.1 Head – Quality Assurance / Chief Executive officer
6.1 Inspection Team:
6.2 The full procedure of vendor approval for bulk consistent supply consist of 4 stages: vendor selection, trail of their sample and its study, vendor visit and final stage of approval / non approval.
THE INFORMATION FLOW SHALL BE AS FOLLOWS
6.3 On arising a need for finding a new vendor along with the existing one to meet our larger requirements, or the need to look for a new vendor to fulfill new material requirements or to have the vendor approved as a second option of supplying goods, the purchase Head shall search for the companies / agencies manufacturing or supplying these. This shall be done through searching the internet or the catalogues for range of products
6.4 Coordination for the trial sample quantity for that particular material shall be done with the Head-QC.
6.5 The Purchase Head shall correspond with the vendor and introduce our company and specify requirements, also requesting to send trial samples from 3 lots of the qty. agreed with Head-QC along with the material specification / COA and test method with reference ( if any ).
6.6 The QC Head shall arrange for the analysis of the same as per our in house specifications / pharmacopeia specifications and on compliance as per our defined standards regarding the quality and the practical suitability of that material, he shall intimate to Head-QA about the status of the same.
6.7 After completing results of the analysis the QC Head shall intimate to Head QA & Purchase Head about the same.
6.8 Head QA shall plan for the audit of manufacturer/supplier site with consultation of CEO.
6.9 The planning of that visit which is to be conducted is then discussed with the CEO and inspection team members (who have already been trained in conducting the audits) shall be called and the purpose of the audit shall be discussed with provide him/her check list for the audit and tell him / her all is to be done. (This visit / audit may be conducted at any time after pre purchased (trial) samples approval to any time after consistent few supply receipt at the plant. It can also be repeated if required in case of any non compliance to the product lot supplied or on receipt of market complaint related to the product we purchase from them).
6.10 During the vendor audit the following documents to be checked and collected for support of documentation:
6.10.1 GMP/ WHO / ISO certificate
6.10.2 Manufacturing License
6.10.3 DMF (If Possible)
6.10.4 Stability data of raw material
6.10.5 List of equipments / Instruments
6.10.6 SOP’s (If required)
6.10.7 Site master file (If possible)
6.10.8 List of products
6.11 On successfully completion of vendor audit Head QA shall approve the vendor and send report to Chief Executive Officer for final authorization.
6.12 On approval and authorization of the vendor after the visit / audit, the vendor’s name shall be added to the list of approved vendors and the Controlled copy of this list of approved vendors shall be sent to the Stores Head as well as Purchase Head. We may or may not choose to procure goods from the listed supplier because of some reason like cost difference, delivery lead-time etc.
6.13 Incase vendor audit not found satisfactory inspection team send non compliance report to vendor for taking corrective and preventive action and inform to CEO.
6.14 The further deletion from the vendor’s list could be result of any non conformance observed during the visit &/or consistently 3 lot rejects of the same supplier of the same material or any other commercial reason. In case of any quality issue observed the Head-QC/Head Production shall intimate to Head QA and Purchase Head to taking corrective action.
6.15 The Purchase, Quality Control, Quality Assurance and production team (if required) shall do the evaluation of the vendor jointly.
6.15.1 Adequacy of building and Facilities:
22.214.171.124 Location and surrounding
126.96.36.199 Ventilation System
188.8.131.52 Air filtration system
184.108.40.206 Air heating and cooling system
220.127.116.11 Lighting & Sanitation
18.104.22.168 Water Supply
22.214.171.124 Disposal of wastage
126.96.36.199 Toilet and bathroom facility
188.8.131.52 Washing facilities and space
184.108.40.206 Segregation of various section
6.16 House Keeping
6.16.1 General cleanliness
6.16.3 Cleaning agent / disinfectant used
6.16.4 Cleanliness of Machine
6.16.5 Written cleaning process
6.16.6 Adequate facility for First Aid
6.17.1 Adequacy of qualified/trained/experienced personnel
6.17.2 Personnel Hygiene
6.17.3 Personnel behavior
6.18.1 Equipments are of appropriate design and of adequate size.
6.18.2 Proper location of equipment to facilitate operation, cleaning and maintenance.
6.18.3 Whether or not the equipment construction material is likely to affect the quality parameters of material.
6.18.4 Follow up of appropriate cleaning and maintenance schedule to prevent malfunctioning and contamination of product.
6.19 Material / Components
a) Proper identification system of material to avoid errors at in issue?
b) Calibration of balance with standard weight’s & measurements authorized by Government)
c) Adequate segregation of material to avoid mix up.
d) Availability of dispensing area.
e) Follow up of approved written sampling procedure.
f) Adequate identification for materials whether they are approved or rejected?
g) Proper segregation of released items from material under test and disposal?
h) Adequate Control of rejected material.
i) Follow up of first-in first-out system.
j) Proper handling & storage of materials to prevent damage, contamination or loss?
k) Adequate retesting frequencies for approved materials.
a) Adequacy and maintenance of manufacturing processes to produce quality product.
b) Availability and follow up of written and controlled manufacturing procedure.
c) Approval and record in case of deviation in follow up of written procedure.
d) Condition and care of ceiling and walls.
e) Control of waste materials.
f) Action and care to clean the utensils, between usages, used in the manufacturing process.
g) Control to avoid cross-contamination during batch change over or product change over.
6.21 Packaging / Labeling and Shipping
a) Adequacy marking system on the shipping containers.
b) Use of approved packaging, labeling material and printing matter to the container.
c) Use of approved packing materials.
d) Control of printed materials.
e) Adequacy of facilities to store the released materials awaiting shipment.
f) Control on cleaning and use of appropriate tanker, trucks and storage tanks.
6.22 Document Control
a) Control of specifications, test methods and other documents.
b) Provision to record and to notify the clients of changes in specification or process.
6.23 Quality Control
a) Availability and follow up of written specifications and validated testing procedure.
b) Adequacy of technical/experienced/qualified staff members.
c) Sampling procedure of materials.
d) Adequacy of instruments, their maintenance and periodic calibration.
e) Adequacy of test procedure.
f) Control for use of approved materials only.
g) Indication of the reason for rejected material and corrective action taken to prevent the reoccurrence of problem.
h) Control program for reagents to assure continued potency.
(i.e. Date of received, date of opening, use before date, proper labelling)
i) Preservation and evaluation of laboratory standards.
j) Control of reference sample and retain sample.
6.24 Facilities in general
a) Prohibition for smoking and eating in the area where necessary.
b) Restriction for entry to production area to unauthorized person.
c) Availability of appropriate toilet facility.
d) Prohibition for jewelry and cosmetics in production area.
a) Adequate support from engineering, production and quality control to meets our requirements.
b) Whether or not the facility appears to be operating in such a manner that a shut or sale of the operation is imminent.
c) Whether or not there appears to be an acceptable quality control department capable of making decision without repercussions.
6.26 Previous Audit Report (if any)
The previous audit report shall be verified for the NCRs documented and the closing of its observations. This shall also be the checklist for the coming audits.
6.27 Vendors Approval Through Checklist
In some case ( if imported material is using or incase of difficult to audit manufacturers site) manufacturer are not qualified by carrying out site audit, QA Head shall send the check list to the respective manufacturer as per Format No. and get back duly filled and authorized by the respective manufacturers.
Manufacturer’s also qualified by applying such system, those who are supplying material to the Corum Lifesciences Pvt. Ltd. since long and in no case material has been rejected or no any difficulty faced during production/packing of the process.
1. Vendor must be able to provide raw material (API) with shelf life not less than 80% from the date of manufacturing.
2. All raw materials (API) shall comply the export specification as per BP/USP/EP which will be used in export manufacturing.
SOP : Standard Operating Procedure
QA : Quality Assurance
CEO : Chief Executive Officer