Third Party Audit Pharma Service in India | Vaayath Consulting Services
Best Third Party Audit Pharma – Pharmaceutical business is a highly regulated business which requires highly skilled and experienced team of experts who are well versed with the current Good Manufacturing Practices and other applicable guidelines. In order to make sure that the businesses continue to achieve quality standards, comply with the regulations, and pinpoint areas for improvement, third party audits are very crucial in the pharmaceutical sector.
Team at Vaayath is deeply committed to the paramount principles of high quality & compliance in the pharma industry. Our company is renowned for offering services for Third Party Audits to Pharmaceutical Companies. Our team of experts who are experienced, knowledgeable, well versed with latest guidelines are the ones who can identify the gaps for the client so that the same can be corrected prior to the regulatory audits. We help pharmaceutical companies meet and exceed all National and International standards viz. USFDA, EMA, PIC/s, Schedule M, WHO GMP, ANVISA and all other standards. Our team also ensures that the products being manufactured are meeting quality norms and are safe and efficacious.
Our team of auditors are transparent, trustworthy and free from any bias which makes us a team of choice for any firm based outside India and who hire us to carry out the supplier audit, third party audit, CRO audit, transportation audit etc. Our clear and unfiltered reporting makes us the agency of choice for carrying out third party audits.
The audit team of our company is well-experienced and conducts complete and detailed audits. We submit a detailed report and recommendations to our clients which makes their decision making informed and quicker. This helps in quicker and effective decision making. Our team consists of experts of GMP, QC, QA, Production, Engineering etc.
Vaayath very well knows the importance of compliance in the pharmaceutical industry. Our audits help you in identifying, assessment and mitigation of associated risks. It also helps to identify the non – compliances and root causes leading to non – compliance.
What is Third Party Audit Pharma?
The third-party audit in the pharmaceutical industry implies the independent examination by an external auditor or team of auditors on behalf of a pharmaceutical company. Third party audits are just like any other regulatory audit carried out by the agencies. The scope and applicable parameters are pre-decided in consultation with the client. There is no compromise with the seriousness of audits. The audits help to understand the state of the regulatory compliance of the auditee. These audits are of paramount importance as they are a way of ensuring that pharmaceutical companies comply with the stipulated standards as may be set by regulatory bodies such as USFDA, MHRA, GCC, PMDA, ANVISA, World Health Organization (WHO), PIC/s and Schedule M etc.
While in a third party audit, a lot of things about the pharma company’s operations are assessed, such as manufacturing processes, quality control systems, documenting rules, and facilities compliance, the aim is to recognize the non – compliances and areas of improvement. Third party audits also help the clients to decide whether the vendor or supplier meets the regulatory norms. It helps to ensure if the company is producing safe, efficacious, and quality pharmaceutical products.
What criteria are evaluated during a Third Party GMP audit?
Prior to initiating any audit, there is a detailed interaction between client and audit team to understand the client’s requirements. During interaction the scope and extent of audit is decided. The reference regulatory guidelines are then decided and accordingly audit plan is finalized and shared with the client. Various sections that are covered during audit but are not limited to:
- Quality Management System (QMS): During audit, the audit team examines the company’s QMS to ensure that it is well-documented, implemented effectively, etc. and includes processes and procedures for continuous improvement.
- Personnel: The qualification, training, and responsibilities of personnel involved in pharmaceutical manufacturing are reviewed to ensure they are adequate. Also, the personnel shall be medically fit and free from any communicable diseases.
- Premises and Equipment: The audit team inspects the manufacturing facilities and equipment provided by the firm to ensure that they are suitable for the intended purpose, properly maintained, and comply with GMP standards.
- Documentation and Records: The audit team reviews documentation practices to ensure that all processes and procedures are properly documented and are maintained accurately and securely. Our audit team ensures that the documentation maintained by the firm follows the principles of ALCOA.
- Production and Process Controls: The audit team evaluates the company’s production processes to ensure that they are well-controlled, thoroughly validated, and comply with GMP standards. The audit team review the processes by ensuring that Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) are well evaluated and documented.
- Quality Control: The audit team assesses the company’s quality control processes to ensure that raw materials, intermediate products and finished products are tested and meet quality specifications.
- Complaints and Product Recall: The auditor reviews procedures for handling complaints and product recalls to ensure they are effective and comply with GMP standards.
What qualifications and experience should a pharma auditing consultant have?
Being an Auditor requires a skillset which is way beyond the technical competence. An auditor shall have certain natural and acquired skills to conduct an effective audit. Being an auditor requires someone to be highly professional and effective in using his knowledge and skills. In short, an auditor shall be a perfect blend of technical and non-technical attributes. Auditing skillset may vary from individual to individual; however, certain competencies are expected from all auditors in order to be recognized as effective auditor:
- Education and experience: A person having prerequisite educational qualification and experience may get trained on procedures and practices to conduct an audit by training institutes competent in imparting such knowledge. He then can associate himself with a team of auditors who have rich experience in conducting audits to get an on-job training. An auditor may gain the knowledge of comprehending the materials presented during an audit through a combination of work experience and training.
- Regulatory Knowledge: Apart from general educational qualifications, an auditor must keep himself updated with latest applicable national and international regulations. He must also train himself in various quality control tools, improvement tools and techniques.
- Communication Skills: Lot of communication do happen before an audit, during an audit and post audit. Poor or inadequate communication may lead to misunderstandings and defeat the overall objective of conducting an audit. Hence, an auditor shall be well trained and have good communication skills. Read our article communication during audit to understand it better.
- Attention to Detail: An auditor shall have an ability to have a close eye on every minutest detail during an audit.
- Professional Certifications: Examples of such certification include Certified Quality Auditor (CQA) or Certified Pharmaceutical GMP Professional (CPGP) that confirms the person’s adherence to auditing excellence.
Taking these criteria and the experience of a consultant into account, pharmaceutical companies will be able to choose a specialist who can carry out a thorough and effective audit. Read our article Auditor – Blend of Knowledge and Skills to understand the qualities of a good auditor.
What are the costs associated with conducting a third party audit pharma?
The expenses that a general pharmaceutical organization spends on employing a third party audit may vary due to many factors. Here’s an overview of the typical costs involved:
- Audit Fees: The biggest cost sometimes is the amount you have to pay to a professional auditing company for the audit work. The fee is calculated based on the complexity level of the audit, the size of the pharmaceutical company, standing of the auditing company, number of man days involved and the size of audit team employed etc.
- Travel and Accommodation: In case of on-site audits, the audit team is required to visit the firm to be audited. In such a scenario, the client has the responsibility of paying for the auditor’s expenses such as travel, accommodation, and others.
- Preparation Costs: The expense of the pharmaceutical company can involve audit-preparation costs, for instance, planning, desk review, internal auditing, collecting documents, and implementing corrections etc.
- Follow-up Costs: In case the audit finds non-conformities or improvement areas, the pharmaceutical company is required to make the effort to correct things as well as undergo follow-up audits.
At Vaayath, we conduct WHO GMP audits as per the latest guidelines of USFDA, ICH, EU, PIC/S, WHO, Schedule M etc. for units involved in manufacturing of API, finished formulation, cosmetics etc. We also conduct vendor audits for our clients. The reports prepared are detailed, covering all the aspects with facts and specimens. The inspection is followed by compliance verification both on site and off site.
Here are Some FAQs
Q1: What is a third party audit in the pharmaceutical industry?
The third party audit is the assessment carried out by an external organization or auditors to check the regulatory compliance of a pharmaceutical company with the national and international standards and best practices.
Q2: Why are audits important?
Audit is a systematic, independent, and documented assessment to determine whether agreed upon requirements are being met and will continue to be met. Audits play a key role in verifying the compliance level of the manufacturing companies with the global standards.
Q3: What does a pharmaceutical auditing consultant do?
The Pharma Auditing Consultants carry out on-site and off-site audits and conduct independent examination on behalf of a pharmaceutical company. Third party audits are just like any other regulatory audit carried out by the agencies. The scope and applicable parameters are pre-decided in consultation with the client.
Q4: How often should a pharmaceutical company undergo a third party audit?
The audit frequency is normally decided on the basis of the risk management policies of the enterprise. Normally, it is advised to carry out an audit at least once a year to verify the compliance level of the firm.
Q5: What criteria are evaluated during a pharma audit?
Prior to initiating any audit, there is a detailed interaction between client and audit team to understand the client’s requirements. During interaction the scope and extent of audit is decided. The reference regulatory guidelines are then decided and accordingly audit plan is finalized and shared with the client. Various sections that are covered during audit but are not limited to Quality management System (QMS), Personnel, Premises, Equipment, Documentation and production controls etc.
Q6: How can a pharmaceutical company prepare for a third party audit?
Preparation can consist of carrying out self-inspections, identifying the gaps and also fixing the non-conformities found in the previous audits.
Q7: What qualifications should a pharma auditing consultant have?
The consultant should have an educational and practical background which includes auditing of companies. And also needs knowledge about the laws and regulations and must have verbal and non-verbal communication skills.
Conclusion
At Vaayath, we conduct GMP audits as per the latest guidelines of USFDA, ICH, EU, PIC/S, WHO, Schedule M etc. for units involved in manufacturing of API, finished formulation, cosmetics etc. We also conduct vendor audits for our clients. The reports prepared are detailed, covering all the aspects with facts and specimens. The inspection is followed by compliance verification both on site and off site.
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