SAP Validation Environment for Pharma Companies

The pharmaceutical industry is responsible for all the development, production and supply of pharmaceutical product. These products are needed to save lives, prevent disease and helps in maintaining quality of life. Preparations must be safe and effective for patients & the general public. Preparation should be such that there is no risk to life or side effect involved.  It must protect consumer. For this we need regulatory bodies who can control the preparation process of these products.
There are International reputed agencies who acts as Regulated bodies for Pharmaceuticals industry

• Food & Drug Administration (FDA) –Relevant for US Market mainly
• European Medicines Evaluation Agency (EMEA) –For European Region
• Drug Controller General of India –For India

Following are the Regulation involved:
GxP: The term GxP means GMP (Good Manufacturing Practices) ,where ‘x’  includes

• GCP (Good Clinical Practices)
• GLP (Good Laboratory Practices)
• GDP (Good Distribution Practices)

What is Validation?
Validation is a process of establishing documents that provides guarantee that if we follow a particular process consistently to produce a product we will be able to meet predetermined specifications and attributes.
Validations in Pharmaceutical Company

1. Process Validation: This involves validation of Manufacturing Process, Plant & Machines, and Manufacturing Techniques etc.
2. Cleaning Validation: This involves validation of Labs, Production, Packaging (Proof of clean), Equipments, Machinery, Instruments, Cleaning Techniques etc.
3. Method Validation: This involves validation of Laboratory methods (R&D…), Quality Verification methods, Analytical Equipment etc.
4. Computer System Validation: This involves validation of Computer Related Systems (any place), Computer Systems & Operating      procedures,   Design, Installation, Performance etc.

V Model Concept for System Validation
Below is universally accepted model popularly known as V model for validation

V Model Concept for System Validation

• User Requirement Specifications (URS) : This step defines what user wants from the system and makes sure that requirement is met
• Functional Specifications: This step defines or creates a document in user understandable format based on URS. This is developed by developer or vendor or service provider.
• Design Qualification DQ: This step provides a document which states that the computer system requirements have been clearly defined and is approved in the form of URS. It also provides document that states all additional system specifications are developed, reviewed and approved.
• Installation Qualification IQ: In this step document is provided which gives the guarantee that all hardware installation aspects are considered according to appropriate codes and approved design. Also software installation is also considered.
• Operation Qualification OQ: In this step document is provided which gives the guarantee that installed system works as specified.
• Performance Qualification PQ: In this step document is provided which gives the guarantee that entire system performs as expected under all operating ranges.

Nikita Chitre

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ArchitectSAP Solutions
SAP. Streamlined.

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
SAP. Streamlined.

Validation of Equipment – Pharma Industry

The concept of validation was first developed for equipment and processes. In 1993 the software for a large radiotherapy device was not designed and tested properly. Several problems resulted in several devices giving doses of radiation higher than intended. Because of that several patients died and several got permanently injured. That is why validation of equipment is required for pharma industry. Following are the steps followed to do validation of equipment in SAP and how to create link between maintenance order and calibration order.
Validation of Equipment after Corrective Maintenance by QC in SAP.

1. When Equipment Breakdown is reported by Production, Maintenance Person gets a break down order. He attends the Breakdown through Breakdown order.
2. After solving the issue Maintenance person submit the Equipment to Production for check/dry run
3. Then Production person will raise a Request for Validation to Quality department.
4. Quality person will validate the Equipment through calibration order. They will check all the parameters, Room Temperature, humidity & also the parts replaced by maintenance etc. according to details mentioned in the Maintenance order.
5. After completion quality person will revert back to Production, Production gives approval to close the Maintenance order.
6. To create link in SAP between Maintenance order and Calibration order, you can use suborder concept.

In SAP create a maintenance order PM01 for break down, and then create a calibration order PM05 as sub order (IW36). You can settle the sub order to a different cost center, so that calibration order cost is settled to Quality department.

Nikita Chitre

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ArchitectSAP Solutions
SAP. Streamlined.