Internal Audit

Audit Checklist for Pharmaceutical Industry

Audit Checklist for Pharmaceutical Industry

To maintain quality assurance, accuracy on multiple data on statistics, and public safety, pharmaceutical industries must comply with various regulations and compliance requirements. The most common aspects behind the audit checklist for the pharmaceutical industry include maintaining good manufacturing practices, quality control, documents, etc. However, a regular audit program in pharmaceutical industries helps such companies detect or identify the potential risk of quality issues and various other legal liabilities. Various policies that govern the distribution, manufacturing, and marketing of pharmaceuticals need to have a legitimate audit checklist for the pharmaceutical industry to ensure and verify various compliance and regulations requirements. To maintain transparency within the industry, an audit checklist for the pharmaceutical industry has to be implemented to achieve trust among the stakeholders, professionals, and customers connected to healthcare departments.

Pros of Audit Checklist for the Pharmaceutical Industry

Performing an Audit checklist for the Pharmaceutical Industry has various benefits, such as:

Assurance in Compliance with Rules & Regulations

The audit checklist for the Pharmaceutical Industry helps to follow the requirements of regulation stated, such as the Food & Drug Administration, European Medicine Agency, etc., so the audit checklist for the Pharmaceutical Industry helps in reviewing the procedures of the companies and identifying and rectifying the compliance issues.

Enhancement in Quality

The audit checklist for the pharmaceutical industry ensures the industry maintains control of the measure of quality through the manufacturing process and maintains GMP (Good manufacturing process) by performing the GMP audit checklist for the pharmaceutical industry and other standards on quality to maintain consistent product quality and safety to ensure the trust of the customer or healthcare departments.

Reduce Risks

The audit checklist for the pharmaceutical industry helps identify the risks related to the manufacturing process, chain of supply, and compliance. It actively addresses the potential risks to minimize financial losses and legal penalties.

Record keeping

The audit checklist for the pharmaceutical industry promotes documentation and keeping of records practices by maintaining an accurate and detailed record of manufacturing processes and activities on quality controls to demonstrate transparency and accountability on regulatory agencies.

Promote Quality and Compliance

The audit checklist for the pharmaceutical industry initiates a culture of quality, compliance and improvements within pharmaceutical companies by following the regulatory requirements.

Legal Perspective to Consider in Audit Checklist for the Pharmaceutical Industry

The audit checklist for the pharmaceutical industry needs to consider the guidelines, which is an important perspective to ensure compliance with the various legal frameworks and guidelines in the pharmaceutical industry.

Good Manufacturing Practices (GMP)

Confirm alignment with GMP guidelines outlined by authorities such as the FDA or the EMA and ensure the proper documentation practices for manufacturing processes, including the operating practices.

QMS (Quality Management System)

The audit checklist for pharmaceutical industry follows the QMS standards to focus on documentation control, management change and improvements. The QMS’s role is to review procedures for handling customer complaints and other related quality issues.

Food and Drug Administrator (FDA)

The FDA inspects medical products and goods facilities that are inspected by experts in the US and engages with the regulatory authorities of India to build confidence to develop quality standards.

EMA (European Medicines Agency)

The EMA deals with protecting and encouraging the health of animals & humans by performing assessment and monitoring of medicines within the European Countries.

Ministry of Health and Family Welfare

The ministry provides advice and guidance to stakeholders related to health development and management and focuses on the growth of the high-potential pharmaceutical industry. 

Central Drugs Standard Organization (CDSCO)

CDSCO is a statutory organization that holds the responsibility to approve drugs, perform clinical trials, define the standards on drugs, and perform various ways to control the quality of drugs or medicines under the Cosmetic Act.

Drugs and Cosmetic Act 1940

According to the Drugs and Cosmetic Act of 1940, the state and central are responsible for dealing with drugs and cosmetics and ensuring the quality, rights, and safety of the medical products distributed to the countries. However, the act assists in granting the license to deal with the drugs and check on the quality and quantity of the drugs imported into the country.

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Quality Control Audit Checklist for Pharmaceutical Industry

The quality control audit is important to perform to ensure the safety and quality of pharmaceutical products.

Testing of Products

The testing of the pharmaceutical products is required to identify purity and attributes of quality as per the approved specification to avoid any kind of discrepancies or legal penalties.

Verification of Methods

The verification of the valuation and verification of the methods for testing raw material and finished products are performed to ensure accuracy and check whether the products meet regulatory requirements or not.

Keeping of Records

The audit checklist for the pharmaceutical industry adapts the quality control procedure to ensure the accuracy of the documents of the activities of quality control, including test results and investigation reports. It also verifies compliance with the Good Documentation Practice (GDP)and the principle of data integrity.

Audit on Quality

The audit checklist for the pharmaceutical industry includes reviewing the quality audits and performing evaluations on rules & regulations with the process of quality control to ensure that the findings are dealt with to meet the audit requirements.

GMP Audit Checklist for Pharmaceutical Industry: Requirements

A GMP audit checklist for pharmaceutical industry is needed to ensure alignment with the standards of rules and quality assurance in pharmaceutical manufacturing procedures. Here are summarized the requirements considered in the GMP audit checklist for pharmaceutical industry:

Testing on Quality

The GMP audit checklist for pharmaceutical industry states the procedure for testing the quality of material, samples, and finished products and maintaining the alignment with specifications for testing.

Verification on Packaging

The GMP audit checklist for pharmaceutical industry includes the verification of packaging and labelling required for pharmaceutical products so there should be a proper inspection of the packaging materials to prevent defects and errors. 

Investigation on Products

The GMP audit checklist for pharmaceutical industry is required to perform an investigation on products related to pharmaceutical industry to check on the specification and quality of the products.

Management of the Methods

The GMP Audit checklist for pharmaceutical industry manages changes in the process of manufacturing and the usage of techniques and equipment. There is an investigation on the products, methods, and equipment to check compliance and implement corrective measures to resolve the issues.  

FDA Audit Checklist for Pharmaceutical Industry: Norms

The inclusion of FDA Audit Checklist for the pharmaceutical industry in broad range of aspects to focus on ensuring compliance with the standards of rules. The FDA audit checklist for pharmaceutical industry varies based on the inspections in pharmaceutical industry, such as:

Alignment with Laws

The FDA audit checklist for pharmaceutical industry requires compliance with the rules of the FDA in manufacturing, new drug applications, handling of complaints, quality and quantity of medical products etc.

Accuracy on Documents

The FDA audit checklist for pharmaceutical industry is required to focus on the accuracy of the documents on manufacturing and control of quality, records, qualifications etc.

Control on Production

The FDA audit checklist for pharmaceutical industry requires control of the process of production and monitoring of the measures or methods of production to prevent discrepancies or defects.

Testing

The FDA audit checklist for pharmaceutical industry is required to perform testing on the quality and stability of the products and check on the alignment with the laws to prevent legal actions.

Inspections on FDA-related Aspects

The FDA audit checklist for pharmaceutical industry performs the inspections by conducting an internal and external audit to perform evaluations with the guidelines, documents, and observations to take actions to prevent loss and legal actions.

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List of Audit Checklists for Pharmaceutical Industry

A checklist for audit in pharmaceutical industry includes various points such as:

  • Internal Quality Controls assessment by internal audits
  • Verification of documents related to the pharmaceutical industry
  • Review of the responsibilities of management and organizational level.
  • Testing and quality management.
  • Compliance with Good Manufacturing Practices, Good Distribution Practices, etc.
  • Measures on safety and security.
  • Controlling the impact of the environment
  • Vendor or supplier quality management by external audit
  • Verification and review of the quality of the products.
  • Testing of laboratory and usage of the equipment.

Documents required to conduct Audit Checklist for the Drug Industry

The key documents required to conduct an audit checklist for drug industry are stated below:

  • The specification details of the products in all stages, such as raw material, intermediaries or finished products.
  • The records of the testing results, process of production and information on products, packaging, labelling, etc.
  • The procedure of standard operations process details for manufacturing, sampling, equipment maintenance, etc.
  • Details of the pharmaceutical industry.
  • Records of the control of quality procedure.
  • Complaints, investigation reports and notification on regulations related to the pharmaceutical industry.
  • Copy of approval of the pharmaceutical industry by the authorities.
  • Copy of license,
  • Registration and Authorization of the pharmaceutical industry.
  • Approval for manufacturing, distribution and marketing in the pharmaceutical industry.

Following the Packaging and Labelling Guidelines

The pharmaceutical industry needs to align with the guidelines on packaging and labelling to maintain the assurance that the pharmaceutical industry is following the laws and guidelines stated by the authorities for functioning. Some of the key points for aligning the practices of packaging and labelling with the guidelines such as:

Compatibility with the Products Packaging

The GMP audit checklist for pharmaceutical industry is required to maintain the proper packaging of the pharmaceutical products by performing testing and ensuring the safety of the product.

Identification of Products

The GMP audit checklist for pharmaceutical industry to check that the packaging is made, quantity, instructions, warning, and precautions.

Safety Measures

The packaging and labelling depend on the safety measures of the packaging of the goods and implementing safety designs as required by the guidelines.

Assurance on Quality

The audit checklist for pharmaceutical industry to establish the methods on quality controls to ensure the accuracy and implement methods by testing, inspections or evaluation on the quality controls.

Guidelines related to Packaging

The guidelines of packaging and labelling are specialized as per the basis of the target markets, outlined under FDA, EMA and relevant authorities.

Assessment of Supplier Process by GMP Audit Checklist for Pharmaceutical Industry

The audit checklist for pharmaceutical industry is performed to conduct an assessment of the qualification of suppliers for the pharmaceutical industry to maintain the safety, and quality of the products and services provided by the supplier to support the operations of manufacturing.

Audit on Supplier

The audit checklist for pharmaceutical industry assesses the supplier’s manufacturing practices, personal qualifications, or relevant standards on quality.

Gather Information

The GMP audit checklist for pharmaceutical industry is performed to gather information on the quality management process of suppliers and inspection or audit records.

Monitoring of Supplier’s Performance

The GMP audit checklist for pharmaceutical industry to monitor the performance of the supplier including the quality of products.

Evaluation of Risk

The GMP audit checklist for pharmaceutical industry conducts an assessment of risk to find out the potential risk related to the supplier’s location, methods, and processes.

How does the Audit Checklist for Pharmaceutical Industry take Initiatives in Improvement in Drug Industry?

The main focus is to serve the tools to comply with regulatory requirements, standards on quality and practices in manufacturing drugs and ensure that there are the measures to be followed by the industry on the pharmaceutical industry to maintain compliance and take initiatives for improvement as per the requirements. The audit checklist for pharmaceutical industry is like a tool to highlight the areas of non-compliance and risks within the manufacturing of the pharmaceutical industry by assessing the various aspects such as design, equipment, documents and control of quality so the checklist identifies these areas and finds the areas for the improvements. The regular audit helps in assessing the areas for continuous improvement. After collecting the findings of the audit, the pharmaceutical industry makes improvements in those areas as per the laws and guidelines. It also helps in using innovative techniques to maintain the process more quality control, and product management more reliably.

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Inspection Pharmaceutical Manufacturing Guidelines

The inspection of pharmaceutical manufacturing guidelines plays a role in maintaining the quality and safety of the products. Authorities such as the FDA, EMA, the Drug and Cosmetic Act and other bodies of regulation provide the guidelines for inspecting manufacturers of pharmaceuticals. The inspector is required to conduct inspections as per the procedures to ensure consistency. The inspector should review the aspects of manufacturing operations in the pharmaceutical industry, such as management, quality control, documents, etc. The inspectors should perform the verification in the pharmaceutical industry as per the guidelines and evaluate the effectiveness of the control of quality measures, testing, etc., to assess the accuracy and the integrity of the procedures and provide the measures or ideas on the corrective measures in the industry.

Conclusion

The audit checklist for pharmaceutical industry helps the industry to maintain compliance with the rules & regulations, quality control or assurance, equipment maintenance etc., to maintain the smooth functioning of the pharmaceutical companies and prevent them from legal penalties or action for non-compliance or not adhering with the rules & regulations. The different policies that govern the distribution, manufacturing, and marketing of pharmaceuticals need to have a legitimate audit checklist for pharmaceutical industry, to ensure and verify various compliance and regulations requirements and maintain transparency within the industry audit checklist for pharmaceutical industry has to be implemented to achieve trust among the stakeholders, professionals, and customers connected to healthcare departments. Audits in the pharmaceutical industry serve as an assurance of quality mechanisms and prevent non-compliance.

FAQs

  1. What is the meaning of a GMP audit?

    The GMP (Good Manufacturing Practices) audit is performed to meet the requirements of the product distribution, process, operations and verification of the safety of the products.

  2. What are the types of audit reports?

    1.      Clean report
    2.      Qualified Report
    3.      Disclaimer Report
    4.      Adverse Report

  3. How are internal and external audits different in the pharmaceutical industry?

    The internal audit focuses on the internal control of the company, and external audits are performed by a third party to prove the performance of the company.

  4. What is the meaning of an audit checklist?

    The audit checklist is a tool for inspection, review of the activities of the industry, and improvement of the loopholes to maintain consistency and prevent the company from legal actions.

  5. What is the full form of QMS?

    The QMS is a quality management system that manages the quality of the products.

  6. What is on the checklist for the pharmaceutical industry?

    The pharmaceutical industry maintains an audit checklist to assist drug manufacturers in maintaining the safety, compliance, and quality of the products.

  7. Who performs an audit on GMP?

    The audit in GMP is performed by the regulatory agencies.

  8. What is a Six Sigma audit?

    The Six Sigma audit is a quality control method that businesses use to reduce defects for improvements.

  9. What is the full form of GDP in the pharma industry?

    The full form of the GDP is good distribution Practices. 

  10. What is the FDA?

    The FDA is the Food and Drug Administration that protects public health and ensures the safety and security of humans and animals in health.

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