SOP Title: Validation and Qualification
- Objective:
To lay down the procedure for Validation and Qualification for Manufacturing Process, Testing procedure or Method, Facility, Utility/System, Equipment/Instruments, Cleaning process etc as a part of Quality Assurance System to ensure Product Quality.
- Scope:
This procedure is applicable to-
- Manufacturing process of product(s)
- Testing procedure/method of product(s)
- Facilities for product manufacturing and storage
- Utilities or system critical to product quality
- Critical equipment and instruments used for manufacturing and testing of product or materials
- Critical cleaning procedures
- Responsibility:
Production Department: To assist in Validation and Qualification executed in the facility, review protocol and report.
Quality Control Department: To carry out testing, prepare test results as specified in the Validation or Qualification protocol, review protocol and report.
Engineering Department: To provide supportive services for execution of Validation and Qualification, review protocol and report.
Warehouse Departments: To assist in Validation and Qualification executed in the department, review protocol and report.
Quality Assurance Department: To prepare, review, approve, protocol and report, execute Validation or Qualification programme, ensure all aspects of product quality and GMP requirements are included in the Validation or Qualification Programme.
- Accountability:
Head QA/All department heads
- Procedure:
5.1 Definitions:
5.1.1 Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
5.1.2 Qualification: Action of proving and documenting that any premises, systems and equipment are properly installed, and/or work correctly and lead to the expected results. Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation.
5.1.3 Validation: Documented series of actions that prove that any equipment, process, procedure, material, activity or system performs its intended functions adequately and consistently, and lead to the expected results of uniform batches that meet the required specifications and quality attributes.
5.1.4 Revalidation or requalification: The repeat of the initial validation or qualification to provide assurance that changes in the equipment, process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.
5.1.5 Validation Master Plan (VMP): A policy document that establishes an overall Validation plan for the company and defines the approach for establishing performance adequacy. It includes the validation work program and details of time-scales for the validation work to be performed, and the responsibilities relating to the plan.
5.1.6 Validation or qualification protocol: A written plan stating how validation will be conducted, including Test parameters, Product characteristics, Production equipment and decision points on what constitutes acceptable results.
5.1.7 Validation or qualification report: A document in which the records, results and evaluation of a completed validation or qualification programme are assembled and summarized. It may also contain proposals for the improvement of processes and/or equipment.
5.1.8 Validation Committee: Representatives of different departments selected and assigned job responsibility to execute validation and qualification on the basis of adequate qualification, experience and training
5.1.9 QA Associate: The QA person who is trained for performing task as per this SOP.
5.2 Procedure
| 5.2.1 | A need assessment of validation and qualification for the facility, utilities/systems, process/procedure, material/products, equipment/instruments, supplier/vendor etc shall be carried out, through discussion related to various aspects of product quality, customer satisfaction, regulatory requirements and continuous improvement of quality management system and described in the Validation Master Plan. | |
| 5.2.2 | Validation and qualification shall be performed:
— for new facility, equipment, utilities/systems, processes and procedures — at periodic intervals — when major changes have been made |
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| 5.2.3. | Validation Master Plan | |
| 5.2.3.1 | A validation master plan (VMP) for manufacturing site shall be prepared in consultation with the Head Production, Head Quality Control, Head Engineering and Head Warehouse and approved by the Head QA Department. | |
| 5.2.3.2 | The validation master plan shall reflect the key elements of the validation programme. It shall be concise and clear and contain at least the following:
— a validation policy — The responsibilities of the members of the Validation Committee. — summary of facilities, utilities/systems, equipment and processes validated and to be validated — documentation format (e.g. protocol and report format) — planning and scheduling for validation and qualification — change control — references to existing documents. |
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| 5.2.3.3 | Validation master plan shall be reviewed and updated as per frequency mentioned in SOP. | |
| 5.2.4 | The Head QA shall constitute a Validation Committee by selecting representatives from Production, Quality Control, Quality Assurance and Engineering Departments as appropriate. This committee will be responsible for the performance of all the validation and qualification activities given in the VMP. | |
| 5.2.5 | Every validation or qualification exercise shall be carried out only on the basis of a written and authorized protocol that sets out the details of the tests to be carried out, and shall be completed by the accumulation of documentary evidence and review of data against agreed acceptance criteria. | |
| 5.2.6 | Validation and Qualification Protocols | |
| 5.2.6.1 | Validation/qualification protocols and report (blank) shall be prepared, numbered, approved and maintained as master document as mentioned SOP. | |
| 5.2.6.2 | As a minimum the protocols shall include the following basic information:
— the objectives of the study — scope — responsibilities — description of procedure/SOPs to be followed — equipment to be used — standards and criteria for the relevant products and processes — the type of validation or qualification — the processes and/or parameters — sampling, testing and monitoring requirements — predetermined acceptance criteria |
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| 5.2.6.3 | The master protocol and report shall be copied and issued for execution of validation or qualification as CONTROLLED COPY after approval as mentioned in SOP. | |
| 5.2.7 | Validation and Qualification Report | |
| 5.2.7.1 | A written report shall be prepared, reviewed and approved after completion of each validation or qualification. | |
| 5.2.7.2 | Reports should reflect the protocols followed and include at least the following information:
— reference to the protocol —objective — scope — responsibilities — description of procedure/SOPs followed — details of material, equipment, programmes and cycles used — procedures and test methods. —deviation and investigation report (if occurred) —recommendation and conclusion —calibration certificates of test equipment/measuring devices where appropriate |
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| 5.2.8 | Revalidation | |
| 5.2.8.1 | Processes and procedures shall be revalidated to ensure that they
remain capable of achieving the intended results over a period of time |
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| 5.2.8.2 | Revalidation shall be performed by two ways
1. Periodic revalidation 2. Revalidation after changes |
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| 5.2.8.3 | Periodic revalidation shall be performed at a frequency mentioned in the Validation Master Plan on the basis of previous history of any process/procedure and risk associated with the system over time. | |
| 5.2.8.4 | Revalidation after change shall be performed, if following changes
found : — changes in starting materials (including physical properties, such as density viscosity or particle size distribution that may affect the process or product) — change of starting material manufacturer — transfer of processes to a different site (including change of facilities and installations which influence the process) — changes of primary packaging material (e.g. substituting plastic for glass) — changes in the manufacturing process (e.g. mixing times or drying temperatures) — changes in the equipment (e.g. addition of automatic detection systems, installation of new equipment, major revisions to machinery or apparatus and breakdowns) — production area and support system changes (e.g. rearrangement of areas, or a new water treatment method) — appearance of negative quality trends — appearance of new findings based on current knowledge, e.g. new technology — support system changes. |
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| 5.2.8.5 | Revalidation after change shall be performed as a part of change control system and change control shall be filed as per SOP. | |
| 5.2.8.6 | Criteria for revalidation after change shall be mentioned in the validation master plan. | |
| 5.2.9 | Requalification | |
| 5.2.9.1 | Requalification shall be performed by two basic ways
1. Periodic requalification- performed at a frequency mentioned in the Validation Master Plan 2. Requalification after changes- changes to utilities/systems, equipment, transfer to another site, maintenance work, major parts etc. |
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| 5.2.9.2 | Changes of equipment which involve the replacement of equipment on a
“like-for-like” basis would not normally require a requalification and revalidation. For example, installation of a new centrifugal pump to replace an older model would not necessarily require requalification or revalidation. |
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| 5.2.9.3 | Requalification after change shall be performed as part of the change control procedure as per SOP. | |
| 5.2.10 | Archival of Validation and Qualification Protocols and Reports | |
| 5.2.10.1 | All the validation and qualification protocols and reports shall be archived in QA Department in a safe and secure manner readily available whenever required. | |
| 5.2.10.2 | Such documents/reports shall be retained for a period as mentioned in SOP. | |
| 5.2.11 | Calibration | |
| 5.2.11.1 | Calibration of equipment/instrument shall be performed:
1. For new equipment/instrument during initial qualification stage 2. For the instruments used for calibration of other instruments 3. At a frequency mentioned in the Validation Master Plan or SOP for individual equipment/instrument. |
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| 5.2.11.2 | Standards used in the calibration shall be traceable to national, regional or international standards and certificates be attached in the report. | |
| 5.2.11.3 | A calibration schedule shall be prepared for all instruments or measuring devices and followed meticulously in the routine operation. | |
| 5.2.11.4 | Calibration of each equipment/instrument shall be performed as per approved procedure. | |
| 5.2.11.5 | Certificates of calibration or reports shall be archived in QA Department after approval. |
- Abbreviation:
| Abbreviation | Expansion |
| QA | Quality Assurance |
| QAP | Quality Assurance Procedure |
| GMP | Good Manufacturing Practice |
| QC | Quality Control |
| VMP | Validation Master Plan |
| SOP | Standard Operating Procedure |
| DQ | Design Qualification |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| URS | User Requirement Specification |
*Note – Ready to use SOP available in “DOWNLOAD” Section.