The purpose of this Standard Operating Procedure (SOP) is to establish a systematic and efficient process for managing product recalls.
1.0 OBJECTIVE
1.1 To lay down the procedure for Recall.
2.0 SCOPE
2.1 This procedure applies to the Quality Assurance Department of ....XXX.....
3.0 RESPONSIBILITIES
3.1 Chemists of QA to follow the SOP.
3.2 Head – QA for compliance of SOP.
4.0 PROCEDURE
4.1 RECALL
Change control is defined as the process of influencing the factors that create change, determining that a change has occurred, and managing the actual changes when they occur. Change control involves evaluating and approving changes in the project baseline scope.
4.1.1 Major Change
Change may have an impact on the identity, quality, purity, strength, stability, safety and efficacy, or physical characteristics of the product.
4.1.2 Minor Change
Change, may not have an impact on the identity, quality, purity, strength, stability, safety, efficacy, or physical characteristics of the product.
4.2 PROCEDURE
4.2.1 Raise change control proposal for any permanent change as described in SOP.
4.2.2 The department/section head should submit the proposal for change in a “Proposal for Change / Modification” format. And the change or amendment shall be recorded in “Amendment in the document” format
4.2.3 Change in the manufacturing process, process control parameters for yield/quality improvement.
4.2.4 Change in manufacturing formula, raw material, and packaging material.
4.2.5 Change in equipment, utilities.
4.2.6 Change in labeling, packaging material.
4.2.7 Change in Specifications/Standard Operating Procedures.
4.2.8 Change/up-gradation in data recording/controlling system.
4.2.9 Relocation of facility/equipment.
4.2.10 Head of originating department shall propose the change to Head – Quality Assurance, along with supporting data (as applicable).
4.2.12 Head – Originating department and Head – Quality Assurance shall judge the feasibility of proposed change based on supporting data and historical data if available.
4.2.13 Quality Assurance shall give the change control number and shall make entries in the “Change Control Record” format.
4.2.14 After assessment of change proposal, Head- Quality Assurance shall classify the change as a major or minor category.
4.2.15 The impact of the proposed change shall be discussed and the necessary action plan shall be documented along with responsibility and target date. Compliance of the action plan shall be reviewed during the approval of the change proposal and closure.
4.2.16 Respective department shall review the change control proposal, as mentioned in the format, “Proposal for Change/ Modification” and required supporting shall be attached.
4.2.17 Head– Quality Assurance shall review the change proposal.
4.2.18 On the basis of justification, scientific rationale, and supporting data, Head – Quality Assurance and Factory Manager shall approve or reject the change proposal.
4.2.20 After approval from the Factory manager, The “Proposal for Change/ Modification” format should be reviewed and approved and authorized by Head Quality Assurances and the Factory manager.
4.2.21 Before the implementation of the approved change proposal, training shall be given to all concerned personnel. (Copy of such training record shall be attached to the change proposal).
4.2.22 Approval or rejection of proposal shall be communicated to the originating department by forwarding photocopy of approved/rejected change control proposal.
4.2.23 After implementation of change, data (as applicable) shall be collected by the originating department and shall be reviewed by Quality Assurance.
4.2.24 After evaluation of data, Head – Quality Assurance shall close the change proposal.
4.2.25 Completed change control formats and the associated documents should be maintained as history.
4.2.26 Minor changes in the Master documents such as spelling corrections, revision/addition of one or two steps in the SOP’s, shall be made through “Amendment” and the corrections shall be regularized during the next revision.
4.2.27 Numbering system for change control proposal is as follows:
4.2.29 The change control proposal number will start from “CCP/YYY/201_/01”, and onwards.
Where
CCP denotes, “Change Control Proposal” YY or YYY denotes Department Code“201_” denotes Year and followed by “/” for separation and then a sequence of CCP number in two digits “01”.
4.2.30 The change control origination and details shall be given as per the “Change Control Record (Year…..)” format.
4.2.31 Specifications/SOP’s/STP’s which are being revised during scheduled review need not be routed through change control proposal.
5.0 ABBREVIATIONS
CCP: Change Control Proposal
GTP: General Test Procedure
PD: Process Development
QA: Quality Assurance
QC: Quality Control
SOP: Standard Operating Procedure
STP: Standard Test Procedure
