Follow
Objective
To provide a procedure to audit a new vendor or re-audit an existing vendor for the active / inactive ingredients and packaging materials.
Scope
This procedure is applicable for approval of all vendors (manufacturers) and suppliers of incoming Active Pharmaceuticals Ingredients (APIs), Inactive ingredients (excipients) and packaging materials, which are required for manufacturing and packaging of finished products so as to control the procurement of materials at (Company Name).
Associated Documents
3.1 SOP No. IONGE016 Appointment of Auditors for Quality Audits
3.2 SOP No. IONGE004 Procedure for Evaluation of Vendors
3.3 SOP No. IONQA042 Annual Product Quality Review
Responsibility
4.1 Head of Quality shall be responsible for constituting an audit team and giving his comment reviewing the audit report.
4.2 Sr. Manager, Quality or his /her nominee shall be responsible for reviewing the questionnaire of vendors for raw/primary packaging materials, testing samples and evaluating the performance of the vendors before going for audit.
4.3 Sr. Manager, Quality or his /her nominee shall be responsible for reviewing the Questionnaire of vendors of secondary packaging materials before going for Audit.
4.4 Sr. Manager, Procurement shall be responsible for sending vendor questionnaire to national and international vendors, finalizing the audit program, taking necessary action on vendors after getting the audit report.
4.5 Audit Team shall be responsible for carrying out the audit program and preparation and submission of vendor audit report.
Definitions
5.1 Raw Material
Active Pharmaceuticals Ingredients (APIs)
A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient).
Inactive ingredients (Excipients)
Any ingredient other than the active ingredient added to a pharmaceutical product to permit it to be formed into the proper shape and required consistency up to shelf life; the vehicle for the pharmaceutical product. Inactive ingredients are sourced either directly from manufacturer or through manufactures representative/ authorized dealers or from traders who stock the several materials from different manufacturers.
5.2 Packaging Material
Primary Packaging Material
Any packaging materials coming into direct contact with a drug product.
Secondary Packaging Material
Any packaging materials other than primary packaging materials. These could be either plain or printed.
Precautions
Not applicable.
Procedure
7.1 Audit Planning and Scope
7.1.1 The Head of Quality/ Sr. Manager, Quality shall plan a GMP/Quality audit at the vendors’ manufacturing facilities to assess the Quality Management systems and compliance to GMP requirements. The vendor shall be for new source of active ingredients required to manufacture of product for regulated market. Once audited, the re-auditing shall be done after every five years. The same shall be applicable for primary packaging material used in product for regulated market and secondary packaging material for all markets.
7.1.2 The approved suppliers of active ingredients and primary packaging material for both regulated and local market shall be evaluated for quality and service each year by QA Department. The approved suppliers of excipients and secondary packaging material for both regulated and local market shall be evaluated for quality and service every two years by QA Department. The manufacturer shall also be contacted through Procurement Department to ascertain any change in their system that might have impact on product quality.
7.1.3 In case there is any quality issue/supply issue found during vendor rating (SOP no. IONGE004) and product quality review report (SOP No.IONGE004) or if there is evidence of significant non-compliance with or change in the QM-System, it shall be the Head of Quality/Sr. Manager, Quality’s responsibility to arrange an unplanned audit. The re-audit may have to be done with prior communication and agreement with the supplier. In that case the re-audit timing will be anytime before 5 (five) years.
7.1.4 A vendor audit schedule (Enclosure 10.4) shall be prepared before beginning of the next year.
7.2 Selection of Auditors
7.2.1 Auditor(s) shall be appointed by the Head of Quality/Sr. Manager, Quality.
7.2.2 The auditor(s) shall be appointed as per SOP No. IONGE016.
7.3 Audit Process
7.3.1 Vendor Audit for Primary/Secondary Packaging Material
7.3.1.1 A visit program shall be chalked out and an audit team shall be constituted.
7.3.1.2 The Head of Quality/Sr. Manager, Quality shall inform Manager, Procurement to finalize the program one month prior to the audit schedule. Once audit schedule is agreed, Head of Quality/Sr. Manager, Quality shall provide an audit agenda to the vendor’s QA Head. Audit will generally be performed as per audit agenda.
7.3.1.3 The filled ‘Vendor Questionnaires’ (Form nos. GE023-01, GE023-02) (if available), annual/biannual evaluation report, previous audit report shall be reviewed during audit.
7.3.1.4 On site the audit shall be progressed as follows:
7.3.1.4.1 An opening meeting shall be arranged with the vendor to inform them about the purpose of audit.
7.3.1.4.2 The information provided by the vendor in the questionnaire shall be checked in case of new sources.
7.3.1.4.3 The production premises including personnel facilities, Building and Equipment maintenance & in-process control procedure shall be checked.
7.3.1.4.4 It shall be checked whether always written manufacturing instruction and related SOPs are followed or not.
7.3.1.4.5 A batch shall be selected. Analytical report, manufacturing documents and approval procedure of the primary packaging material shall be checked. In case of secondary packaging material a product shall be selected and all the steps of printing operation shall be checked according to procedure.
7.3.1.4.6 The Quality Control Laboratory facilities shall be checked for adequacy of testing equipment (if applicable) and calibration of instruments or measurement systems
7.3.1.4.7 It shall also be checked whether all the tests are carried out as declared and the results meet specification.
7.3.1.4.8 General Housekeeping, complaint management, material control and safety measures shall be observed and records shall be reviewed.
7.3.1.4.9 A closing meeting shall be conducted and the vendors shall be briefed about their requirements and their overall performance.
7.3.1.5 A vendor audit report shall be prepared and submitted to Head of Quality/Sr. Manager, Quality for his/her comment along with Vendor Audit Summary Report (Form no. GE023-03). The report shall also contain the comment on the approval status (provisional approval/ approval/non approval) in case of new source.
7.3.1.6 The original copy shall be kept in Quality Assurance Department and photocopies shall be sent to Procurement Department to take necessary action with the vendor. The Procurement Department shall send a copy to vendor.
7.3.1.7 Follow up with vendor for compliance to the recommendations suggested in the audit report shall be done by QA through Procurement Department.
The unique document numbering for Vendor Audit Report shall be done as under:
VAR_001/12
Where,
VAR is abbreviation of vendor audit report
001 is the sequential number
12 is the year
QA shall issue the vendor audit report number and maintain the log register as per enclosure 10.5
7.3.2 Vendor Audit for Active Ingredient
7.3.2.1 A visit program shall be chalked out and an audit team shall be constituted.
7.3.2.2 The Head of Quality shall inform Sr. Manager, Procurement to finalize the program one month prior to the audit schedule. Once audit schedule is agreed, Head of Quality/Sr. Manager, Quality shall provide an audit agenda to the vendor’s QA Head. Audit will generally be performed as per audit agenda.
7.3.2.3 The filled ‘Vendor Questionnaires’ (Form nos. GE023-01, GE023-02) (if available), annual/biannual evaluation report, previous audit report shall be reviewed during audit.
7.3.2.4 In case of new source the related documents shall also be reviewed:
Vendor’s brochure or Site Master File
Analytical Procedure, Method validation & COA
Stability data as per ICH guideline
Drug Master File (open part if available) etc.
Validation and Qualification etc.
7.3.2.5 The audit procedure shall be as per steps 7.3.1.4 to 7.3.1.7.
7.4 Audit Report Submission
7.4.1 The audit team shall submit a report to Head of Quality /Sr. Manager Quality for onward submission of same to Vendor through procurement department.
7.4.1 The report shall include all non-conformities, which are observed during the audit, including suggestions and corrective actions with time frame that are drawn up together with the vendor.
7.4.2 The Vendor shall then submit a post implementation report to Head of Quality/Sr. Manager, Quality through Procurement Department.
7.4.3 Head of Quality/Sr. Manager, Quality shall evaluate the post implementation report and decide further action including recommendation for Preventive Action (if required).
7.4.4 The Sr. Manager, Quality or his or her designee shall compile the corrective and preventive records with the Audit Report.
