Procedure: Managing GMP Regulation Changes

Transcription

1 Effective Date: TBD Procedure: Document information, authorship and approvals Author signs to confirm technical content Prepared by: Job title: Signature: Date: Subject matter expert reviewer signs to confirm technical content Reviewed by: Job title: Signature: Date: Quality representative signs to confirm document complies with quality management system Authorised by: Job title: Signature: Date: Document is current if front page has Controlled copy stamped Page 1 of 8

2 Table of Contents 1. Purpose 3 2. Scope 3 3. Roles and responsibilities 3 4. Procedure Communication of changes Preparation for review meeting Regulatory change review meeting Change implementation Change implementation completion Records to be kept 6 Document is current if front page has Controlled copy stamped Page 2 of 8

3 1. Purpose The purpose of this procedure is to describe the process of identifying, assessing, and managing changes to Good Manufacturing Practice (GMP) regulations applicable at PharmOdol to ensure continuing compliance to the GMP regulations. 2. Scope This SOP should be used by staff who: Perform self inspection activities as per SOP-995: Internal Audits schedule, complete and document GMP regulatory change review meetings at the PharmOdol site. The scope also meets the principles outlined for compliance to GMP requirements related to Self Inspection. For example: refer to PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE (Part I), Chapter 9 Self Inspection. The following are outside the scope of this SOP: Product Quality Reviews (PQR) (refer to SOP-998: Product Quality Review) management reviews (refer to SOP-999: Management Review) 3. Roles and responsibilities Role Quality Manager Responsibility Implementation of this procedure. Overall accountability for the GMP/quality compliance at the site Chairing the regulatory change review meetings Notifying the Site Quality Review Team (SQRT) of changes to the GMP regulations applicable at the site Providing resources to implement regulatory changes on time Site Quality Review Team (SQRT) Attends review meetings Evaluates the proposed regulatory changes and develops recommendations Reviews recommendations and draft responses Identifies action items, resources and responsible persons required for compliance with the changes. QA Associate Implement changes as per the appropriate Quality Management System (QMS) Managing regulatory change review documentation Document is current if front page has Controlled copy stamped Page 3 of 8

4 3.1. Site Quality Review Team Site Quality Review Team (SQRT) is a multidisciplinary body consisting of the following members and or their representatives: Quality Manager Manufacturing Manager Technical Services/Engineering Leader Regulatory Affairs Leader Quality Associate Subject Matter Experts (SME) - others to be invited as needed based on expertise or involvement in regulations being reviewed, approved and otherwise decided. 4. Procedure 4.1. Communication of changes The Quality Manager is responsible for implementing a GMP regulatory intelligence and surveillance program to effectively monitor GMP regulatory changes and industry trends to ensure that the site remains compliant to current GMPs. A regularly scheduled meeting of the SQRT is used to discuss GMP regulatory changes and track site activities to ensure continued compliance. Notifications of GMP regulatory changes may be received as follows: Automatic notifications - received by subscribing to online GMP regulatory notification services and industry association newsletters. The recipient accesses the online draft guidance documents and information notices to download / review the content and circulate for review. For example: Manual reviews - a routine scheduled task is set up to survey the individual GMP regulation and industry association websites for change notifications. Upon confirmation of a regulatory update, the Quality Manager shall notify the Site Quality Review Team (SQRT) and schedule a meeting to review the potential changes and site compliance status Preparation for review meeting When scheduling the GMP regulatory change meeting, the QA Manager shall prepare the review meeting agenda. This shall include: identification of the changes in the regulation and description of expectations for compliance identify the implementation period Document is current if front page has Controlled copy stamped Page 4 of 8

5 initiate the gap analysis highlighting the regulations to be discussed forward the meeting agenda and any relevant document to the SQRT for review along with the meeting notification. Each member of the SQRT, or their representative, must perform an impact assessment of the changes to their department. The details are documented and returned to the Quality Manager to collate all the information in one location. The collated information is then circulated to the SQRT for information prior to the meeting Regulatory change review meeting The meeting is chaired by the Quality Manager in accordance with the prepared agenda and all members of the SQRT must attend the meeting. Managers unable to attend may send a representative if they are fully briefed and are given authority to act for the manager in their absence. Absent managers will receive minutes and may submit input to the Quality Manager. SQRT shall review the identified regulatory changes thoroughly and determine the: nature and scope of the prospective changes gaps against the existing processes and procedures impact of changes on the company process, systems and procedures actions required to address the changes / gaps identified resources required for change implementation / gap remediation (including assignment of responsibility, timeframes and allocation of human, equipment, know-how and other resources) responsible person to be assigned for each proposed action. The QA Associate shall update the GAP Analysis Register and document the meeting minutes. A permanent record of these details shall be kept and distributed to meeting participants (and any absent managers) for their action Change implementation The staff assigned responsibility for actions within the SQRT review meeting shall initiate the appropriate quality system as per the table below. If the action is to implement a prospective change remediate a gap in the existing process then raise a change control as per SOP-994: Change Control Procedure investigate the gap as per SOP-996: Managing Deviations close any actions as per SOP-997 Managing Corrective and Preventative Actions (if required) 4.5. Change implementation completion The completion and progress of the change actions shall be reviewed by: SQRT during the next scheduled regulatory review meeting Document is current if front page has Controlled copy stamped Page 5 of 8

6 Senior Management during the review of Quality Management System (QMS) in accordance with SOP-999: Management Reviews Records to be kept The location and retention period for management review records are specified in SOP- 993: Control of Records. The following documents are to be retained: agenda for the regulatory review meeting minutes of regulatory review meeting approved Gap Analysis Register / documents formal reports and supporting documents presented at the review other records of actions: records of work carried out to achieve gap remediation and compliance with regulations. Document is current if front page has Controlled copy stamped Page 6 of 8

7 Definitions Term CAPA PQR QMS SQRT Definition Corrective and Preventive Action Product Quality Review Quality Management System Site Quality Review Team Document Information Revision History Revision Modified by Change Control No. Description of Change 01 Jo Bloggs TBD New document. Associated forms and procedures Doc. No. SOP-993 SOP-994 SOP-995 SOP-996 SOP-997 SOP-998 SOP-999 Document Title Control of Records Change Control Procedure Internal Audits Managing Deviations Managing Corrective and Preventative Actions Product Quality Review Management Review Associated records Doc. No. FRM-999 PIC/S PE Document Title Meeting minutes PIC/S Guide to Good Manufacturing Practice for Medicinal Products (Part I, Part II, Annexes) DOCUMENT END Document is current if front page has Controlled copy stamped Page 7 of 8

8 SOP-999 Effective Date: TBD Attachment 1: Gap Analysis Register Regulation reference: Regulation title: Effective Date: Department: Reviewer: Assessment Date: Requirements Gap Analysis Remediation Part / Annex Chapter Clause No. Clause as written Changes associated with the clause Gap Assessed (Y/N) Compliance Status (Compliant / Non-Compliant) Proposed action to address gap Hours Required Change Control required Assessment performed by: (Print name) Signed by: Date: Assessment approved by: (Print name) Signed by: Date: Document is current if front page has Controlled copy stamped Page 8 of 8