SAP System Validation and Compliance Methodologies for Pharma Companies

The SAP system setup for Pharmaceutical companies is same as any other industries/organizations; just Pharma companies are regulated by special Government bodies by the state. This is because Pharma companies manufacture medicines and other products which are essential for maintaining good human life and hence are sensitive entities. To launch any new pharmaceutical product in the market, it has to be rigorously tested and test results documented and are verified by the regulating bodies. To carry out SAP system validation of a pharmaceutical industry which has implemented SAP, one should gather basic knowledge of all interfaces of SAP and the FDA guidelines for the product about the interface to internal and external hardware and software taking into account.
There are different regulatory bodies for pharma companies in different countries like:

• Drug Controller General of India – For India
• FDA – Food and Drug Administration for US
• EMEA – European Medicines Evaluation Agency

Following are the reasons that explain the need of regulation for Pharmaceutical industry:

• Quality assurance – Pharmaceutical companies produce drugs, medicines and medical equipments which are used by hospitals worldwide for treating patients. Thus the manufacturing process of these must be very hygienic, safe and of top quality.
• Government Policies – The Government has some guidelines, rules and procedures for pharmaceutical companies and it has its dedicated team of representatives who conduct regular inspection checks along with surprise visits to the pharmaceutical companies. This is to ensure that best practices are being followed while producing life saving materials.
• Upgradation – With the changing world and market scenarios, the rules and procedures need to be analyzed, studied and modified, if required. Also new steps or rules may be added.

Following are the general basic steps involved in all the Validation processes:

1. Gap Analysis – GAP here means incompleteness or missing links. GAP analysis means analyzing the SAP system through available documentation, and current status of SAP with reference to the guidelines of Regulatory agencies and attempt to find out from available implemented systems.
2. Plan of Action – Based on our gap analysis we create action plan along with client, and decide which gaps can be closed technically and which are to be attended by other procedures. There may be some offset in closing the Gaps.
3. Risk Assessment – After the plan of action, we will carry out detailed Risk Assessment of relevant modules. If required the Human resource module and distribution part is also analyzed. In this step, we determine the important transaction codes and classify them into typical three categories as per GAMP guidelines. The further validation procedure is based on this classification.
4. Validation - This step is the formal start of validation process with the creation of VMP or Validation Master Plan. Then comes the protocols preparation.

Computer System Validation (CSV)
This method is to verify whether the computer systems are delivering their part. It includes hardware, software and the firmware. This method requires detailed documentation of the software or application used by the manufacturing process in the Pharma company.
The documentation involves:

• List of hardware required
• Minimum hardware required to maintain the SAP support system
• Functional specification about the requirement
• Applications and benefits
• Test results with comments/feedback.

Following are some of the problems that may arise during a validation project:

• Difficulty in understanding the requirement if the documentation i.e. the functional specification is not proper.
• Secondly, in most of the cases, the validation group is assigned task only after the SAP has been implemented in the industry and is in function for more than year. So here it is difficult to recognize what output the system was supposed to produce. To overcome this problem we should seek guidance and expertise of experienced functional consultants of all modules.
• We also need to define the present requirements. For this we have build a central team which consists of all kinds of users as well as senior representatives from Quality Assurance, Quality Control, IT Dept and Validation and partial finance persons.

Abhijeet Kapgate

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ArchitectSAP Solutions
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