Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
PQR form refers to the Process Qualification Record form, which is a document used in various industries to record and document the qualification of a manufacturing process. It is typically used to demonstrate that the process is capable of consistently producing products that meet specified requirements. The PQR form includes information such as the process details, materials used, testing and inspection results, and any necessary corrective actions taken. It serves as a record of the process qualification and is often required by regulatory bodies or customer specifications.
Who is required to file pqr form?
The PQR (Prescribed Questionnaire) form is primarily used by companies listed on the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE). These companies are required to file the PQR form as part of their compliance obligations under the Securities and Exchange Board of India (SEBI) regulations. The PQR form seeks various disclosures related to the company's financials, operations, governance structure, and other relevant information.
How to fill out pqr form?
Filling out a PQR form typically involves the following steps:
1. Understand the purpose: PQR stands for Product Quality Review, which is a document that evaluates the quality of a product over a certain period of time. It includes information on manufacturing processes, quality control measures, deviations, and any corrective actions taken.
2. Gather the necessary information: Before filling out the form, collect all relevant data related to the product, such as manufacturing records, analytical test results, stability data, and any customer complaints or non-conformances.
3. Identify the appropriate sections: The PQR form may consist of multiple sections, including but not limited to product information, manufacturing process, analytical data, deviations, complaints, stability data, and conclusions. Determine which sections are relevant to your product and focus on those.
4. Provide accurate and complete information: Fill in the required details throughout the form accurately and comprehensively. Include information on the product name, batch or lot numbers, manufacturing location, responsible personnel, and relevant dates.
5. Describe the manufacturing process: Detail the manufacturing process, including equipment used, process parameters, and any changes or improvements made during the reporting period. Emphasize process controls, quality checks, and validations.
6. Include analytical data: Present analytical test results performed on the product, confirming its quality and compliance with specifications. Provide data on various quality attributes, such as potency, purity, identity, dissolution, or any other relevant tests.
7. Address deviations and non-conformances: If any deviations or non-conformances were encountered during the reporting period, describe them in detail. Explain the root cause, impact on product quality, and any corrective or preventive actions implemented.
8. Consider stability data: If applicable, include stability study results demonstrating the product's shelf-life and any changes observed over time.
9. Conclude the PQR: Evaluate the product's quality, compliance, and adequacy of controls based on the data presented. Summarize key findings, identify potential risks, and recommend any improvements or actions needed to maintain product quality.
10. Review and submit: Before finalizing the form, review all information provided for accuracy, completeness, and coherence. Make sure the form adheres to any specific guidelines or requirements from regulatory bodies, if applicable. Submit the completed PQR form to the appropriate department or personnel responsible for review and approval.
What is the purpose of pqr form?
The purpose of the PQR form (Procedure Qualification Record) is to document the essential variables and parameters used in the welding procedure qualification process. It provides detailed information about the welding procedure and its qualification, including details about the materials, processes, equipment, and test results used. This record is often required in industries such as construction, manufacturing, and engineering where welding plays a crucial role in joining metals and other materials. The PQR form serves as evidence that a particular welding procedure has been qualified and meets the necessary standards and requirements.
What information must be reported on pqr form?
The PQR (Periodic Quality Report) form is used to report information regarding the quality of a pharmaceutical product. The specific information that must be reported on the PQR form may vary depending on regulatory requirements and specific company policies, but usually includes:
1. Product and manufacturing information: This includes details about the specific product being reported on, including its name, batch number, dosage form, strength, and manufacturing site.
2. Changes and updates: Any changes or updates related to the product formulation, manufacturing process, control strategy, or critical process parameters should be reported.
3. Quality control testing: Information on the results of quality control tests performed on the product, including assay, impurity testing, dissolution testing, and stability studies. This helps assess the quality and consistency of the product.
4. Complaints and adverse events: Any reported complaints or adverse events associated with the product should be documented and reported. This includes information on any recalls, investigations, or corrective actions taken.
5. Standard operating procedures (SOPs): Documentation of any changes or updates to the SOPs related to the product's manufacturing, quality control, or distribution.
6. Analytical methods: Details about the analytical methods used to test the product, including any changes or updates to these methods.
7. Deviations and non-conformances: Documentation and information regarding any deviations or non-conformances observed during the manufacturing or testing process, with an explanation and actions taken to resolve them.
8. Regulatory compliance: Information regarding any regulatory inspections, findings, or audits related to the product, including corrective actions taken to address any non-compliance.
9. Stability data: Data on the product's stability, including real-time and accelerated stability studies, packaging configuration studies, and any updates to the product's shelf life or storage conditions.
10. Assessment and trending: Analysis of the data collected, including any trends or observations related to the product's quality or manufacturing process. This helps identify areas for improvement or further investigation.
It is essential for the PQR form to be accurately completed and submitted within the specified time frame to ensure compliance with regulatory requirements and demonstrate the product's quality and compliance with current Good Manufacturing Practices (cGMP).
What is the penalty for the late filing of pqr form?
The PQR form typically refers to the Product Quality Review form, which is used in pharmaceutical manufacturing. The penalty for late filing of the PQR form may vary depending on the specific regulations and guidelines of the regulatory authorities in your country or region. It is advisable to consult with the appropriate regulatory agency or seek legal advice to determine the specific penalties and consequences for late filing of the PQR form in your particular jurisdiction.
How do I modify my pqr form in Gmail?
It's easy to use pdfFiller's Gmail add-on to make and edit your pqr welding form filling up and any other documents you get right in your email. You can also eSign them. Take a look at the Google Workspace Marketplace and get pdfFiller for Gmail. Get rid of the time-consuming steps and easily manage your documents and eSignatures with the help of an app.
How do I fill out the pqr welding pdf form on my smartphone?
Use the pdfFiller mobile app to complete and sign pqr sample on your mobile device. Visit our web page (https://edit-pdf-ios-android.pdffiller.com/) to learn more about our mobile applications, the capabilities you’ll have access to, and the steps to take to get up and running.
How do I complete pqr form on an Android device?
Use the pdfFiller mobile app and complete your pqr welding format and other documents on your Android device. The app provides you with all essential document management features, such as editing content, eSigning, annotating, sharing files, etc. You will have access to your documents at any time, as long as there is an internet connection.