Validation in the pharmaceutical industry involves multiple departments working together. Quality Assurance (QA), Quality Control (QC), Production and Engineering all add their own knowledge to ensure the validation of processes, instruments, services, tests, etc. The responsibilities for validation must be laid out in the standard operating procedure, description of the validation process and related protocols.
One serious weakness of pharmaceutical companies is that they think of validation exclusively as the duty of Validation Department. Validation team can organize the work, but it cannot provide the expertise of Production Department, laboratory testing abilities of Quality Control department, technical knowledge of Engineering department or ensure independent quality control of QA.
Some of the major responsibilities of QA include:
The engagement of QA must be appropriate considering the project being performed in accordance with the relevant responsibilities. The approval should be a documented quality meeting.
If analytical methods are validated, QC may perform studies on such factors as specificity, accuracy, precision, linearity, range, and robustness, if they are applicable to the proposed use of the method(s). The protocol must contain the characteristics to be tested as well as acceptable criterion for their testing.
If process validation is carried out, QC may analyze the raw material, in-process samples, and finished product. In cleaning validation, it is possible for the laboratory to test the samples of swab/rinse to check for residue of the active component, cleaning agents, or any microorganisms, where applicable.
QC is to confirm:
While conducting validation, Manufacturing staff is responsible for operating equipment, recording key metrics, obtaining samples and documenting results. They must adhere to the approved BMR, validation protocol and relevant SOPs.
Some of the responsibilities of manufacturing include:
It is also important to remember that production specialists can provide experience-based knowledge in the process of protocol development as protocols may establish unrealistic parameters for operation or fail to take into consideration usual interventions that can lead to meaningless results due to their inapplicability.
Common Engineering activities include, but are not limited to, support of equipment design, checking of installations, qualification tests and analyses of problems connected with the equipment.
Responsibilities of Engineering may also involve the following:
It is necessary for engineering to cooperate with QA, QC and owners of the system prior to executing any changes that may influence the operation of the validated system.
This is a practical distribution of common roles, but it does not follow a universal chart of regulatory bodies. The exact distribution depends on the facility, validation SOP, type of study and other needs.
In cases of complicated studies, a responsibility matrix can indicate who is responsible for the preparation and approval of results of a particular process.
Before carrying out the process, it should be verified that the plan enumerates who is responsible for what, who must sign things in order to continue with the process and what documents must be created. When executing the process, areas must inform each other about unexpected findings right away rather than waiting until a report is generated.
During a regulatory audit, inquirer may ask who authorized the treatment protocol, who validated any deviation from the protocol and who confirmed that the system is adequate for its purposes. All involved parties must know what their position is and help out other members of the process.
Good validation requires clear ownership and coordinated technical work. In production, the process is executed; in QC, analytical data is collected; in Engineering, the right equipment is provided; in QA, compliance is checked. As long as these roles are defined and executed, validation can be done in a verifiable way and will not just be about signed documents.
Quality Assurance: Quality Oversight and Compliance Decisions
QA has the responsibility of overseeing the processes that are related to validation in the pharmaceutical industry thus ensuring that the practices being used comply with the pharmaceutical quality system, GMP rules as well as the approved practices. QA does not just sign the protocols and reports once other department finishes with their processes.Some of the major responsibilities of QA include:
- Going through and approving validation protocols and reports along with any changes made in accordance with the authorization matrix of the site.
- Ensuring that the validation process is in accordance with the previously approved processes and risk assessments.
- Making sure that all the deviations, unexpected results and changes are appropriately documented and assessed.
- Checking whether the corrective action and preventive actions are adequate.
- Making sure that the conclusions made are justified and documented.
- Ensuring that the validation records can be controlled, traceable and retrieved.
The engagement of QA must be appropriate considering the project being performed in accordance with the relevant responsibilities. The approval should be a documented quality meeting.
Quality Control: Analytical Tests and Laboratory Controls
Quality Control may aid validation through the production of reliable analytical and microbiological data. The scope of work for Quality Control is determined by the type of study being conducted and the nature of the laboratory's involvement in the plan for validation.If analytical methods are validated, QC may perform studies on such factors as specificity, accuracy, precision, linearity, range, and robustness, if they are applicable to the proposed use of the method(s). The protocol must contain the characteristics to be tested as well as acceptable criterion for their testing.
If process validation is carried out, QC may analyze the raw material, in-process samples, and finished product. In cleaning validation, it is possible for the laboratory to test the samples of swab/rinse to check for residue of the active component, cleaning agents, or any microorganisms, where applicable.
QC is to confirm:
- The appropriateness and integrity of test and analytical methods with validation and verification status.
- The instruments have been calibrated or otherwise qualified, as required.
- Standards, reagents and reference materials are appropriate and traceable.
- Calculations and chromatograms, worksheets and raw data support the reported results.
- An OOS, OOT or other unexpected results are managed following the established procedures.
- Any repeat analysis must have documented scientific and procedural justification.
Production: Demonstrating Consistent Process Execution
Manufacturing is responsible for performing manufacturing operations according to validated instructions and ensuring that validation runs are consistent with the intended product and conditions of use.While conducting validation, Manufacturing staff is responsible for operating equipment, recording key metrics, obtaining samples and documenting results. They must adhere to the approved BMR, validation protocol and relevant SOPs.
Some of the responsibilities of manufacturing include:
- Training personnel to perform the process as required.
- Recording actual conditions and observations.
- Monitoring key metrics and in-process controls.
- Using the approved sampling plan and communicating with QC.
- Reporting any deviations from the process and any strange occurrences.
It is also important to remember that production specialists can provide experience-based knowledge in the process of protocol development as protocols may establish unrealistic parameters for operation or fail to take into consideration usual interventions that can lead to meaningless results due to their inapplicability.
Engineering: Equipment, Utilities and Technical Reliability
Engineering plays a crucial role in providing the technological base for the validation of the manufacturing equipment and systems. Engineering responsibilities usually start before the validation of the process because the equipment has to be appropriate for being used for its defined purpose.Common Engineering activities include, but are not limited to, support of equipment design, checking of installations, qualification tests and analyses of problems connected with the equipment.
Responsibilities of Engineering may also involve the following:
- Participation in review and preparation of qualification design documents, including technical specifications.
- Assistance or completion of installation qualification (IQ) and operational qualification (OQ).
- Verification of needed instruments, alarms, controls and operational ranges.
- Participation in performance qualification (PQ) process and qualification of utilities.
- Maintenance of approved drawings, equipment manuals and technical documentation.
- Assessment of equipment failures, changes and maintenance from the viewpoint of validation.
It is necessary for engineering to cooperate with QA, QC and owners of the system prior to executing any changes that may influence the operation of the validated system.
How Departments Should Work Together
While the roles may often intersect in practice, the roles are to be clearly defined. It can be helpful to determine responsibility at every stage of the validation process.| Activity | Main contribution |
| Preparation of protocols | The validation team together with relevant technical departments |
| Execution of processes | Production/ designated system owner |
| Analytical tests | QC or a qualified testing laboratory |
| Qualification of the equipment and utilities | Engineering together with the validation assistance |
| Investigation of deviations | The department responsible for the technical aspects |
| Supervision of GMP and quality system | Quality assurance |
| Final approval | Authorized personnel as per site procedures |
This is a practical distribution of common roles, but it does not follow a universal chart of regulatory bodies. The exact distribution depends on the facility, validation SOP, type of study and other needs.
In cases of complicated studies, a responsibility matrix can indicate who is responsible for the preparation and approval of results of a particular process.
Preventing Gaps in Validation Accountability
Validation issues often occur when one area of an organization presumes that another area has already completed an important step. For example, Manufacturing presumes Engineering has validated the instrument and Engineering presumes QA has validated the measurement. If there is uncertainty about who is going to do what, opportunities for critical evidence are lost.Before carrying out the process, it should be verified that the plan enumerates who is responsible for what, who must sign things in order to continue with the process and what documents must be created. When executing the process, areas must inform each other about unexpected findings right away rather than waiting until a report is generated.
During a regulatory audit, inquirer may ask who authorized the treatment protocol, who validated any deviation from the protocol and who confirmed that the system is adequate for its purposes. All involved parties must know what their position is and help out other members of the process.
Good validation requires clear ownership and coordinated technical work. In production, the process is executed; in QC, analytical data is collected; in Engineering, the right equipment is provided; in QA, compliance is checked. As long as these roles are defined and executed, validation can be done in a verifiable way and will not just be about signed documents.
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