In the 21st century, electronic records are most preferable option in every field. Pharma / Biopharma business is continuously growing, simultaneously new regulations has been strengthened on routine basis. To full fill the requirement, SAP-ERP system is the best option for tracking and traceability of each GMP activity including financial growth.
The Pharma industry operates under drug regulations imposed by various drug administrations. This necessitates continuous monitoring and tracking. A high profile ERP package is essential to meet this requirement. For monitoring online activity and to ensure Good Manufacturing Practices, it is necessity to implement electronic documentation generation and controls.
Generally, there is a tendency to develop isolated systems inhouse to cater to various functions such as sales & distribution, purchase, finance & accounts and HR & Payroll. There are many functionality limitations within each of these software and, above all, no linkage. Other important issues are: lack of data security, poor GMP compliance, difficulty in tracing problems, and efficiency planning across multi-centric organisations. Hence there is strong need to have a single ERP system to tie-up all the processes.
You must have two things in place beforehand as you start discussion: a dedicated team comprising techno-functional champions and user requirement specification (URS) / As-is.
Above two will give immense benefit while selecting the suitable ERP package as well as implementation partner who has domain expertise. You will also have fair idea about what the ERP is going to do for you and what not. A score card based on various discussions may additionally help you finalise the ERP package and implementation partner.
The ERP implementation deserves full attention from top to bottom and needs to be considered as a separate project which will motivate the entire team. Many modules are available in SAP ERP but generally Finance (FI), Controlling (CO), Material Management (MM), Production Planning (PP), Sales and distribution (SD), Plant Maintenance (PM), Quality Management (QM), Document Management System (DMS) & HR with Payroll are most preferable. A Document Management System is a very good eco-option and need lot of efforts during and after
implementation for on-line activity. Based on organisation needs, project systems module can also be considered. Figure 1 provides the SAP R / 3 modular structure overview.
Based on organisation size, it is vital to have a team for SAP implementation may comprise of 10 to 20 dedicated employees who are champions / experts in their respective functions and 10-15 external consultants who are experts on individual module with domain expertise and continuous support related to Infrastructure, Basis and ABAP programming from in house IT department.
After finalisation of SAP modules and implementation partner, the implementation exercise should begin. General timeline is about six months to one year (depending on size of the organisation as well as age of company because it has direct impact on management of old data). The greatest challenge is to collect data, arranging it in specified format of SAP and then transferring relevant data from existing systems to SAP after verification. The shift from separate state databases (in-house software) to a centralised distribution model (SAP) is expected to eliminate duplication of data, reduce operational costs, reduced cycle times, improve customer satisfaction and provides management with visibility across a unified supply chain for improved forecasting and optimised inventory management.
It is important to define unique sequential numbering system in SAP for various GMP functions for better traceability such as: batch numbering, QC reference, analytical report, change control, deviation, laboratory investigation, out-of-specification, out-of-trend, non-conformance report, document request, log book issuance request, equipment malfunction, etc. All batch records, data recording sheets, certificate of analysis and certificate of conformance can be uploaded in the system for convenience and immediate access and it can be linked with material code and production planning for printing and recording real-time data.
The 'Document Management System' module in SAP provides online access to standard operation procedures, specification, master process and control records, batch process and control records, data recording sheet, protocol, validation report standard testing procedure, artworks etc. All the documents can be linked with material code so that when inspection lot of material is created, SAP can provide a link to the current approved documents (e.g. Inspection plan, Specification, Test methods, BPCR) found in Document Management System.
Adoption of any major system changes is normally difficult. Major emphasis is to be given to adoption of best practices in place of habitual process and this requires serious training. Core team members should ensure the of training various end users so as to reduce chaos during implementation by planning and continuous interaction with end users. There is a major challenge during implementation of ERP at the C&F agent level which is spread across the country / international location and the cost of the project, including hardware, software, networking and training.
After implementation, every module is expected to run well in real-time and it is easier to dig-out the information whenever required by the user. Core team members shall continuously monitor the system and provide support to end user as well. The organisation should be able to track the production at every stage with quality parameters including cost and efficient production planning. The system gives entire traceability from manufacturing to distribution including all information about purchasing, vendor, material used lot, quality attributes and critical process parameter, intermediate, drug substance, drug product, dispatch, delivery and stocks. Successful implementation of the complete business processes onto the ERP system on time and within the stipulated budget depends on full support from top management as well as depth knowledge, experience and dedicated efforts of the implementation team.
The key benefits for a centralised system can be planted during planning stages by careful business blueprinting and adoption of standard processes wherever possible. The organisation can also take this opportunity to be environment friendly by considering the elimination of forms, logbooks and other paper work.
The most important benefit is the online data available to top management which helps them in analysis of what happened and designing new strategies for the future.
Additionally, it will reduce manual time and effort for documenting the sampling with electronic sample data that would able the SAP R / 3 users to track the location status of samples with real time access.
Another key benefit is the ability to automatically evaluate results based on current specifications. Another key benefit could be the automated supplier scorecards used to track supplier performance.
To host the SAP landscape, robust infrastructure is suggested and it can be finalised with the help of implementation partner as under:
Multiple high-performance servers to host SAP Development / Quality / Production landscape
The controls in place for moving configuration / development from development server to quality server and then to production server are by transports. All the transport activity should be controlled by change control system to manage requests for changes. Once proposed changes are approved, changes should be transported to the quality server for testing and then to production.
The primary objective of implementing security in the SAP system is to ensure that only authorised users are able to access the systems, these users are only able to perform the tasks required for their specific job functions.
Roles shall be used to define rights to execute SAP transactions with specific conditions which is called as SAP 'Authorisation'. These roles can be grouped into business process-related SAP roles, and further grouped in to SAP composite roles or positions.
As the organisation will be performing various business processes / transactions through SAP, it is very important to have proper procedure for the data backup and recovery of SAP server. The IT team should perform online backup of SAP using standard DB13 command. it is recommended to use tape library as a data backup device. Full backup should be taken every day to minimise the loss to business data. Retention period for SAP online backup tape media should be minimum one week. Provision for offsite storage of backup media in fire-proof storage cabinet.
The approach considered for existing system at IBPL is retrospective approach as SAP System is already in use (Refer Figure 2). During the validation process, efforts must be made to find out available information on specifications, documentation and current practices of the organisation.
The transaction list is required to identify the processes with consideration of GMP standpoint in order to establish which processes need to be validated and which do not, so that the associated effort can be significantly focused on GMP critical processes. The GMP categorisation is decided on the basis of the pertinent GMP guideline.
The SAP ECC 6.0 ERP application software falls under the category 4 & 5–Configurable software packages as well as customised software as defined in GAMP 5 guidelines. The GAMP 5 categorisation and SAP ECC 6.0 system detail categorisations is summarised in Table 1.
Validation scope
A validation master plan (VMP) document needs to be developed to list specific validation deliverables and activities required during each phase. This ensures that the validation role and approach is well understood and agreed upon sponsors, project team members, and process owners.
The content of the VMP forms the baseline for managing and delivering the validation process for project according to deliverables and approaches identified within VMP.
Validation steps
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 analysing 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.
The checklist prepared in GAP analysis has current requirement defined as acceptance criteria. Total number of GAP check list has been prepared for each module as below (Refer Table 2). Find some examples of GAP analysis of each module (Refer Table 3). The applicability covers SAP ECC 6.0 system Hardware and software infrastructure and Application server.
2. Plan of action: Based on the gap analysis organisations can create action plan along with client, and decide which gaps can be closed technically and which are to be attended by other procedures.
Approach for the action plan
When the negative results of the spot checks are realised, determine if Gaps are due to improper configuration / implementation (in case of system is capable). Note down the actual observation and intimate to core team to correct the same.
When the negative results of the spot checks are realised, determine if Gaps are due to the system’s incapability to satisfy the requirements, than note down the observations and suggest implementing immediate manual procedure to control the system’s requirement and informing to core / technical team (Implementation partner) to implement the same through system control
When the negative results of the spot checks are realised, determine if Gaps are related to non-availability of documents / records, then note down the observations and intimate to project coordinator to define further action plan.
3. Risk Assessment: After the plan of action, carry out detailed risk assessment of relevant modules. In this step, the organisation must 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.
Risk assessment requires not only the identification of the immediate effects of the risk but also the long-term impact on the business of those effects. These effects must take into account a wide variety of issue including impact on regulatory compliance, financial impact and company reputation with customers and suppliers
Determine the likelihood (frequency or probability) of an adverse event occurring.
Assess probability of detection
Identify if the adverse event can be recognised or detected by other means in the system. Adverse event having high probability of detection, may not pose serious threat because it can be recognised quickly and suitable corrective action taken to mitigate its impact. If adverse event has a low probability of detection, then the risk condition need to seriously consider a review of the design or the implementation of alternative procedures to avoid the event.
Overall priority
Overall priority is calculated using multiplication of the all three assessment ranking and decided based on following table (Refer Table 4).
After Risk analysis has been completed, overall report has been prepared with mitigation plan and how much risk will be reduced after mitigating the risk.
This consists of server, client, Hardware, network components and Network infrastructure, operating programs with utilities. The installation qualification activity also includes identification of live database and test database.
This consists testing of information flows in terms of functions and transactions at the level of individual processes. The test strategy is completed with functional and negative tests which are identified as measures in individual transaction wise risk analysis activity.
We had a good opportunity to validate the system not only from a business process point-of-view but also from IT security. Infrastructure was also part of validation activity where in we checked / challenged various parameters on servers as well as at clients end. This helped to boost up our confidence on our systems.
At the time of implementation, based on our assumptions, we created roles in SAP for assigning to users for their routine activities. At the time of validation activity, we had a better understanding of roles and responsibilities and we could realign roles / authorisations based on actual business needs.
The performance qualification consists of the Integration and Process flow verifications which describes the inter relationship between all modules, systems and procedural controls.
In the Validation Summary Report the results will be summarised with the test objectives.
In the traceability matrix all the requirement specifications will be mapped with individual qualification activity.
Once system is validated and all process has been running smoothly, it is highly recommended to monitor the SAP system periodically for the improvement. Annual review report (applicable EU guideline for product review) which summarizes the identified gaps, any deviation or error, changes made during year. It may also include the summary of
In a nutshell, following success factors could be considered during SAP ERP implementation:
Involvement / commitment of top management and all key users
Knowledge transfer from implementation partner to in-house team.
Shaligram Rane is currently Sr. General Manager–Quality (QC & QA) of Intas Biopharmaceuticals Ltd. He is associated with the Intas for the past seven years where he has been directly involved in technical, techno-commercial and business progression of five rDNA products and is currently involved with 10 other biosimilars. He holds extensive experience in the quality control and quality assurance (QC and QA) of pharmaceuticals, biosimilar products and services for the Indian, ROW and regulated markets. His academic qualifications (M.Sc. M.Ed. and Ph.D.) are in the area of Organic Chemistry and Analytical Chemistry.
Prashant Modi has 11 years of experience in designing, implementing and maintaining enterprise level IT Infrastructure & Services like systems and networking as well as SAP ERP application as Basis Admin and MM consultant. He worked with ITES organisations like Allied Digital Systems, Wipro and HCL at esteemed client sites like Torrent Pharma and ONGC.
Kruti Shah is Sr. Executive in Quality Assurance dept. of Intas Biopharmaceutical Ltd. She is B. Pharm with seven years experience. She is core team member of Document Management System (DMS), project coordinator during SAP-ERP validation and having expertise in handling of Material Management, Quality Management and Production planning modules of SAP-ERP.
