VALIDATION:
PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES
The purpose of this SOP is to lay down procedure for selection Qualification and approval of Service Providers for Outsourced activities of manufacturing sites
This procedure shall be applicable for approving, controlling and reviewing of Service Providers supporting outsourced activities relevant to cGMP systems covered as a part of Pharmaceutical Quality Systems.
DEFINITION OF THIS VALIDATION PROCEDURE
Service Provider: A service provider is an organization or an individual who provides professional or expert advice/ service in a particular element of pharmaceutical Quality Management. Service provider can be a Subject Matter Expert and/or a consultant etc.
Technical Team: Technical team shall comprise of personnel from corporate departments and/or site departments, having adequate technical knowledge/experience to evaluate and approve the outsourced service.
On Hire: Temporary use for an agreed service.
On Contract: Hired to work for a specific service with predefined timeline (not permanent employment.)
On Board: Individual or group taken on board for a special service, committed to support the assigned service on a regular continuous basis.
ABBREVIATION(S)
OEL: Occupational Exposure Level
PDE : Permitted daily exposure
HBEL: Health Based Exposure Limit
SME: Subject Matter Expert
RESPONSIBILITY
Technical Team:
The technical team consisting of representatives from QA/Originating department shall be responsible for selection and evaluation of Service Providers for outsourced activities
The technical team shall be responsible for developing and approving a ‘Technical Service Agreement’ with Service Providers prior to outsourcing activity.
QA/originating department shall be responsible for timely monitoring of activities outsourced to service provider along with identifying any changes to technical agreements
Head-QA/Designee-QA:
Shall be responsible for approval of Service Providers for outsourced activities based on the evaluation of assessment made.
Head-QA shall be responsible for taking approval from Contract Giver for any outsourced activity impacting its product or process.
Plant Head:
To ensure implementation of the defined system.
PROCEDURE
Any activity (Relevant to product or process or Quality system or equipment or facility or training etc.) relevant to cGMP covered under Pharmaceutical Quality System and which is outsourced shall be performed through a Qualified Service Providers
The Service Provider shall be used in case if there are no in-house expertise or resources at site or there is urgency of work or an expert opinion is required.
The service required from service provider can be of following type:
On Hire
On Contract
On Board
Head QA shall give approval to service providers on the basis of if service provides accredited by NABL, BIS or any highly regulatory approval such as USFDA, EUGMP, EAEU, WHO(General) etc.
The Service Provider shall be used for following but not limited to:
Any service related to consultancy for remediation activities due to any deficiencies identified during Audit from regulatory Agency or Internal Audit or Customer audit etc.
Any service related to specialized activity identified based on new or revised regulatory Guidance’s (For example: Toxicological assessment and PDE determination by Toxicologist).
Any service related to gap assessment of any specific Quality System element at site or across all the sites.
Any services related to Validation/maintenance/Preventive Maintenance etc. which requires specialized subject matter expert.
Any services for specific investigation which requires specialized subject matter expert.
The qualification of Service Provider shall involve following steps:
Identification service provider
Defining scope of activities expected and time lines outlined for service under evaluation.
Selection of service provider.
Qualification of the service provider.
Development of Service Technical Agreement.
Identification of Service Provider:
The Service Provider shall be identified based on the following but not limited to:
Previous experience, working on the same or similar subject at any specific site(s).
Recommendation from Marketing Partner or Marketing Authorization Holder or Qualified Person or Vendors (Such as Equipment or Component or Materials or Software system)
Industrial resources.
Resource of service provider to meet the target timeline.
Defining scope of activities expected and timeline outlined for service under evaluation.
Scope and timelines shall help in understanding the requirements for resources and capability from Service Provider.
The scope of outsourced activity shall define type of service(s) required from service provider.
The scope shall outline the site or number of sites for which services is required from service provider.
The timelines for completion of service under evaluation shall be defined based on following:
Critically of the risk identified.
Commitment provided as a part of quality system.
Deadline provided in applicable regulatory guidance for its implementation.
Routine timelines.
Selection and Qualification of Service provider.
The technical details or organizational details or Curriculum Vitae (CV) shall be requested from the identified Service Provider for evaluation of following:
Educational Qualification.
Professional / Practical Experience in similar area / function.
Availability of resources.
Competency and technicality.
Audit to service provider/or on half of approval by regulatory authority.
The qualification shall be required to evaluate service provider’s capability to carry out effectively and satisfactory the scope of work identified for the outsourced activity.
The technical aspects of the service provider shall be evaluated by a technical team having suitable knowledge and cGMP requirements related to the outsourced activity covered under the scope.
Educational Qualification
The service provider shall have appropriate qualification in relevant function for which service is under evaluation.
In-certain cases for specialized service, educational qualification as defined in the SOP be evaluated.
Note: For example Toxicologist providing service for Toxicological assessment and PDE (HBEL) determination shall have appropriate education in Toxicology/
Pharmacology/ Pharmaceuticals.
The consultant/External trainer shall be a diploma holder/graduate in science/ Pharmacy /Engineering to perform laboratory training/Technical training.
Professional/Practical Experience
The Service Provider shall be selected based on the professional experience in Pharmaceutical Industry in the relevant function which is under evaluation.
Note: For example; a Toxicologist shall have adequate expertise and experience in toxicology/ pharmacology, familiarity with pharmaceuticals as well as experience in the determination of health-based exposure limits such as Occupational Exposure Levels (OEL) or Permitted Daily Exposure (PDE).
He/She shall have similar experience in the similar role in the area of service, providing relevant experience of the subject matter/ service provided.
In certain cases similar type of service provided to reputed pharmaceutical shall be considered for evaluation i.e. project handled.
Discussion shall be held with service provider about their understanding and knowledge about the requirement defined in the current regulatory guidance shall be considered for evaluation.
Evaluation of Resources
The Service Provider shall have expertise in the Subject Matter and/or relevant functions of service defined under the scope.
The number of resource personnel required for completing the scope outlined shall be evaluated so that the timelines can be met.
Note: While evaluating a service provider emphasis shall be given to service provider’s infrastructure, sources for up gradation of requirements (Knowledge, skills, etc.), and historic success rate (if applicable).
In certain cases where the service is related to execution of experimental studies or testing then the technicality, competency and the required resources available with Service Provider shall be understood.
Note: Based on the type of service, which can impact the product quality, onsite audit shall be performed.
In-certain cases the authenticity of data which shall be provided by service provider shall be understood based on the technical discussion.
Note: Reference of all the technical data should be enclosed in their documents.
Competency
Discussion shall be held to understand the following:
Skills or areas of expertise of SMEs who will provide support for the services under the scope of evaluation.
Success from previous assignments in similar type of services.
Expertise or ability to provide services based on new or revised or updated regulatory guidance which are made effective from time to time.
Expertise in identifying gaps or areas of improvement and understanding of recent Regulatory requirements.
Skills related to decision making with sound judgment and communication through a language which can be easily understood.
Also success from previous assigned shall be evaluated with respect to completion of scope of work within the timelines or addressing the requirements defined under the scope.
Discussion shall be held with the Service provider to understand the association of SMEs with their organization (On board or contract or hired), so that timely support can be provided in-case of any query identified.
Certain types of services shall involve evaluation of competency of Service Provider with respect to coordination or work with Regulatory Agency for resolving any queries or understanding the requirements.
Certain type of services shall require evaluation of competency related to answering of queries during any onsite Regulatory inspection.
Evaluation of Sample Documents
Certain services shall involve evaluation of template of sample document and comparison with the requirements defined in SOPs or requirements enlisted as per Regulatory Guidance’s.
Based on the satisfactory evaluation, service provider shall be approved By Head-QA/QC.
Development and Approval of Service Technical Agreement
There shall be written contract made with Service Provider for clearly defining, establishing and controlling the outsourced activities along with responsibilities of each party under the scope of outsourced activities.
In-case of any outsourced activity impacting products belonging to a Contract Giver, then the same shall be discussed prior to the service agreement.
The contract between Mfg. site and Service provider shall cover the following; related to outsourced activities but not limited to:
Scope of outsourced activity
Responsibility, timelines and communication process
Information and knowledge necessary to carry out the contracted operations correctly in accordance with the applicable procedures from mfg. site and Regulatory Guidance’s or requirements if any.
In-case of any outsourced activity related to product which shall be executed at Service Providers facility, then information related to any hazards which can have impact on the premises, equipment, personnel, other material, other products etc.
The agreement shall define the requirement that Service Provider shall not subcontract to any third party of any the outsourced activity covered under the scope.
The agreement shall define the requirement that Service Provider shall not make any unauthorized changes outside the agreement which may adversely affect the outsourced activity.
If any need arising for subcontracting, then the same shall be executed only after approval through a formal qualification process.
The agreement shall define requirements on control on records if any related to outsourced activity and maintain the confidentially of the credential throughout the lifecycle of the service.
The agreement shall define the requirement to permit audit of Service Providers by Mfg. site on need basis.
Contract shall be renewed based on the additional activities if identified and based on completion of the on-going contract.
Periodic Review of Outsourced Activity
The outsourced activity shall be monitored and reviewed for the performance of the services covered under the scope so as to identify and implement any improvement or changes.
The improvement or changes shall be identified based on the updated information or knowledge gained or new/updated Regulatory Guidance’s during the lifecycle.
ATTACHMENTS
Attachment-I Qualification record of service provider for outside source activities.
Attachment-II Template for List of Agreements
