Importance of CAPA Achieving Cost Effective Quality Management in the Pharma
                     Importance of CAPA: Achieving Cost-Effective 
Quality Management in the Pharma
What is CAPA?
• CAPA stands for Corrective Action and Preventive Action. CAPA is a systematic 
approach to resolving issues in different industries, including pharmaceuticals. In a 
pharma company, it is crucial to ensure the safety and efficacy of drugs. CAPA 
identifies and tackles problems related to drug manufacturing, testing, and 
distribution.
• The process includes detecting the problem, finding its root cause, and 
implementing corrective and preventive measures.
• ISO 90001 is a widely used global standard for quality management in the 
pharmaceutical industry. It helps companies implement a framework for ensuring 
high-quality products and customer satisfaction. Certified to this standard shows 
that a company produces a good quality product that meets customer 
expectations.
• In this article, we will explore the importance of CAPA in detail and how it 
contributes to the pharmaceutical company. In the end, we will also mention one 
of the best pharma manufacturing companies in Ahmedabad.
What is the importance of CAPA in the 
Pharmaceuticals industry?
• ● Successful Audits
• In pharma manufacturing, cGMP violations are common due to human errors and 
environmental factors. Regulatory bodies inspect the organization’s risk mitigation 
and quality improvement approach during their audit.
• ● Savings
• CAPA has advantages for pharmaceutical manufacturers, such as saving costs, 
increasing revenue, and improving processes.
• ● Overall efficiency
• CAPA can reduce operational costs and promote innovation, leading to more 
efficient processes and systems. It can help increase market share by offering cost-
effective, quality products.
• ● Improves products quality
• Using CAPA in the pharma manufacturing industry can increase your product’s 
quality. CAPA identifies and investigates the problems in the pharma products to 
prevent them from happening again.
When should a pharmaceutical Company consider 
CAPA?
• ● Removing Binders
• It’s important to know when to use CAPAs. Corrective actions are used to prevent 
the reoccurrence of a specific problem, while preventive measures are used to 
avoid any occurrence for all pharma products or operations.
• ● Effective Quality System
• A renowned pharma company always uses an effective quality system, like the 
many pharma companies in Ahmedabad. A good CAPA program uses a well-
documented system to identify the root causes of deviations.
• ● Well Structured Investigation
• A thorough investigation focusing on the main reason is crucial to establishing a 
successful CAPA. Identifying the correct root cause is necessary to prevent the 
CAPA from reopening.
What is the process of CAPA in the Pharmaceutical 
industry?
• Step 1: Identification The first thing to do in the CAPA process is to find the 
problem and its source. 
• Step 2: Evaluation In this stage, look at the problems first and then find their 
solution. Check if any necessary action is needed. 
• Step 3: Investigation The problem is investigated more closely during this step to 
plan for the next actions. The investigation usually involves:
• Step 4: Analysis In this step, finding the main cause of the problem is the main 
objective. Examine the availability and ensure the information is accurate and 
preserved to reflect the main cause of the problem.
• Step 5: Action Plan In this step, succeeding in the previous steps is necessary. It 
involves the sequence of actions necessary to implement corrective and 
preventive measures.
• Step 6: Implementation In this step, you need to implement the action you have 
planned.
• Step 7: Follow UpAfter you execute the CAPA activity, it is important to follow up. 
It will help you measure the effectiveness of the corrective and preventive actions.
Contact Us
• Address: 203, Anmol Business Centre, Vrundavan Colony, Near Navrang School Six 
Roads, Navrangpura, Ahmedabad, Gujarat 380009
• Phone: 079 2640 5517
• Email: [email protected]
• Website: http://www.mediwinpharma.com/