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AstraZeneca Pharma Poland: GDP standards and SAP implementation

Pharmacy requires validation

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GDP (Good Distribution Practice) standards precisely define requirements for processes relating to trade in medicines. This applies also to IT systems in use. Therefore, the implementation of the corporate SAP system at AstraZeneca Pharma Poland has been carried out together with the validation of this IT solution.

Implementation goal at AstraZeneca

It took almost a year to complete the project of the SAP corporate standard implementation at AstraZeneca Pharma Poland. It included also the adjustment to specific business and legal features of the Polish company, which is part of the corporation.

Launched in May, 2009, the system comprises new SAP functionalities in the field of finance, controlling, materials management, and in particular sales and distribution. Four parties were engaged in the project: AstraZeneca Pharma Poland, the British headquarters of the corporation, a consulting company designated by the corporation, and BCC as a Polish implementation partner.

“Our project is not an easy undertaking – not only due to the engagement of as many as four companies, but also because it entails numerous organizational changes at AstraZeneca in Poland. Projects of this kind are challenging to implementation companies.
Therefore, we decided to cooperate with BCC – a company with a large experience in conducting SAP rollouts in an international environment”, says Ewa Strzelczyk, Director of Marketing and Sales Department at AstraZeneca Pharma Poland, a project coordinator.

One of the main goals of the SAP implementation in the Polish company of the corporation was – in addition to unification with the corporate system – to get closer to final customers, which became possible through obtaining precise data from pharmacies. It was achieved by changing the company’s business processes, including changing the management of distribution channels, and integrating the SAP system with IT systems of consignment warehouses delivering medicines to pharmacies.

The implementation effect is, among other things, more precise information on sales of medicines grouped by various criteria, e.g. a geographical location or time (e.g. bigger sales of a medicine in the season of increased allergic symptoms), and also by chains of pharmacies.

The SAP solution for Poland was designed jointly by employees of AstraZeneca, a consulting company designated by the corporation, and BCC consultants. BCC participated also in the system validation – first of all in the phase of preparing a concept and tests.

Validation: obligatory and useful

Good Manufacturing Practice (GMP) standards are requirements applicable in the pharmaceutical industry that apply to actions that must be taken, and conditions that must be met at the production stage so that medicines and medical materials intended for distribution are of the highest quality.

This high quality must be also maintained further in a distribution process, which is, in turn, governed by GDP standards. They guarantee safe receipt, transport, storage and issue of medicinal products. Like GMP, GDP standards require that all processes relating to the trade in pharmaceuticals be validated.

This obligation is included in the European Union legislation (the European Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use).
In Poland, the Pharmaceutical Law Act of September 6, 2001 and the Ordinance on the Good Distribution Practice procedures of the Minister of Health of July 26, 2002 are the legal basis of GDP.

As mentioned earlier, the Good Distribution Practice includes rules of storing medicinal products, rules and procedure for their receipt and issue, transport and loading conditions as well as proper running of a pharmaceutical warehouse.

The law requires a company to establish and maintain a quality control system compliant with its rules. Thus, in the pharmaceutical industry, also an IT system in use must be consistent with GDP rules and the quality system applicable in a given company. Therefore, the SAP system at AstraZeneca was validated.

Validation consists in obtaining documented evidence that a specific process, method or system will repeatedly lead to results meeting specific criteria of acceptance. The GDP standard also provides for storing documentation so that authorized persons or controlling authorities can at any time obtain access to data.

The purpose of the IT system implementation is also to obtain an efficient solution that performs defined tasks. Validation is an ally in this process since its goals include:

  • obtaining a full description and documentation of the system,
  • reducing the probability of errors,
  • providing repeatable procedures and ways of conduct,
  • ensuring a constant, high level of quality of data being processed.

Validation is carried out in parallel with implementation. Testing of the system and documenting of these tests are a part of both the validation and the very implementation process. Validation activities must be included in an implementation work schedule. It can be concluded that upon achieving its goals, validation becomes, as it were, a part of an IT system and increases its value for the company.

Testing, documenting, approving

Validation involves confirmation of correctness by checking, examining, testing and documenting of the established facts.

It wouldn’t be possible to deploy an IT system without meeting requirements resulting from quality assurance system procedures applicable at AstraZe-neca. What’s more, it is impossible to introduce changes in a system that already functions without testing and documenting the correctness.

Piotr Maciąg, Finance Director, AstraZeneca Pharma Poland

We are now closer to the customer
At present, in the Polish and global market for the distribution of medicinal products, the dominant business solution is a model in which pharmaceutical companies sell their products to wholesalers. Wholesalers acquire thereby the title to these goods and the power to dispose of them on their behalf. Then they sell medicines to other entities, i.e. smaller warehouses or pharmacies and hospitals. In effect, before a product is finally received by a patient, it is a property of several successive entities.
The direct sales system is a solution in which a manufacturer remains the only owner of medicines in the whole distribution channel, i.e. until they are sold to pharmacies. However, the manufacturer does not deliver them through his own structures. A corporation selects a specific number of warehouses out of entities already operating in the market and signs agreements for the supply of its medicines with them. In fact, these entities act as logistics service providers, who  on behalf of a medicine owner  store, transport and administer the process of selling goods directly to pharmacies.
A distributor who will be finally delivering goods to a pharmacy is selected by the pharmacy itself out of the distributors who established cooperation with a medicine owner.
The SAP solution implemented by AstraZeneca supports precisely such a cooperation model in the supply chain. The direct sales system is an alternative to a classic model of distribution of medicinal products. This solution provides public pharmacies and pharmaceutical outlets with the same high standard of service, which in turn influences the optimization of the distribution process.Piotr Maciąg
Finance Director, AstraZeneca Pharma Poland

Both during the SAP system implementation and after deploying it, all changes were introduced first in the test system and were validated. Only the approved and signed documentation of tests is a permission to transfer changes to a production system.

It is necessary to obtain the documentation of this kind for implementations of IT systems in the case of pharmaceutical companies that may be subject to a pharmacovigilance inspection.

Michał Wasilewko, Sales Manager, AstraZeneca Pharma Poland

“Validation means, to a large extent, producing of documentation. For us at AstraZeneca in Poland, this is important in that this documentation concerns specific processes carried out in our company. The course of processes in our subsidiary partly differs from that in the company’s headquarters in Great Britain, for instance. BCC consultants verified the documentation not only for its consistency with the SAP system operation, but also in terms of specific features of the Polish company. They identified, for instance, that a part of the documentation applicable at AstraZeneca corporation does not apply to Poland since a given process is carried out in a different way in our company,” underlines Michał Wasilewko, Sales Manager, AstraZeneca.

All SAP functional areas implemented at AstraZeneca Pharma Poland were subjected to the validation procedure.

In the case of an IT system, a validation check, examination consists in its testing. The SAP solution at AstraZeneca was subjected to various tests. They were divided into module, integration, acceptance tests and tests simulating a productive operation.

BCC consultants were engaged in acceptance tests and tests simulating a productive operation. During their performance, the experience gained while designing the solution for AstraZeneca Pharma Poland and the knowledge of specific features of processes carried out here came in useful.

In acceptance tests and tests simulating a productive operation, also cooperating consignment warehouses whose systems were being integrated with the SAP system of AstraZeneca took part.

For acceptance tests, BCC consultants prepared:

  • test requirements – a list of conditions for recogniz-ing the functioning as correct, e.g. a proper value of goods movement posting,
  • test cases (scenarios) – input data, a course of its processing and expected processing results.

In acceptance tests, not only the correctness of functioning, but also the correctness of adjustment to specific features of processes in Poland was verified. The tests resulted also in system change requests concerning mainly the system parameterization.

“Discussions between employees and BCC consultants during system validation tests contributed to creating proposals for introducing useful changes in the SAP system. Their implementation came in very useful in practice. For example, in our industry, it is very important to track a series (a batch). At the beginning, all goods in transit were visible in the system as stock in  “one bag” and it was possible to find out to which warehouse specific goods were transported only  on the basis of material documents.
Through splitting this stock, we immediately see what and in what quantity is transported to a concrete entity with which we cooperate. This allowed us to obtain a higher quality of our solution,” says Michał Wasilewko.

In tests simulating a productive operation, it is essential to process data that is as close as possible to actual data, in the quantities simulating the actual system workload.

The test data from consignment warehouses were processed in runs set up according to target parameters. By the way, patches and some improvement changes were tested. The simulation of the productive operation was a good opportunity to verify a much bigger number of master data.

The important element of validation is also the documenting of evidence. Therefore, during the SAP implementation, it is not sufficient to carry out tests and to conclude that the system works properly.
For purposes of the quality assurance system, a special documentation of tests was prepared. The task of BCC consultants was to verify them and a final approval was the responsibility of AstraZeneca Pharma Poland employees.

The documentation of tests for validation purposes must contain a description of testing activities and test results. At AstraZeneca, the documentation included both descriptions of the process run in the SAP system and illustrations of this run – views of screens filled in with test data and run results, e.g. a view of a properly created material document. In the case of testing the lack of authorizations of a user to run a given transaction, the test result is a message informing about this fact. Its illustration is also included in the documentation of tests.

The documentation was checked for its consistency with the run in the SAP system and the run specific for the solution applied at AstraZeneca in Poland. The documentation was submitted to AstraZeneca employees for signing only after it had been verified.

The latest guidelines of the European Commission for pharmacy refer to the quality assurance for the whole software lifecycle – its development, imple-mentation, qualification, acceptance, operation, modification, requalification, maintenance and possible withdrawal.

As mentioned earlier, without validation of changes in the test system, they may not be introduced into the production system in use. Thus, validation does not end together with the implementation completion. The need for it arises again when we want to develop a solution to ensure that changes are proper from the point of view of GDP.

AstraZeneca Pharma Poland is a Polish company, which is a part of one of five largest pharmaceutical corporations in the world. The corporation was established as a result of merging Astra AB, a Swedish company, with Zeneca Ltd., a British company. At present, AstraZeneca employs over 400 people in Poland. Like in other countries, AstraZeneca not only provides patients with modern medicines, but also conducts research. It has one of the biggest clinical research departments out of all pharmaceutical companies operating in Poland.
More information at: www.astrazeneca.pl

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      1. Personal data is processed pursuant to Article 6 (1) (a) of the Regulation of the European Parliament and of the Council (EU) 2016/679 of April 27, 2016 – the General Data Protection Regulation
      2. The data controller is SNP Poland Sp. z o.o. with its registered office in Złotniki, ul. Krzemowa 1 62-002 Suchy Las. Contact data of the Data Protection Supervisor: dpo.pl@snpgroup.com.
      3. Consent to data processing is voluntary, but necessary for contact. Consent may be withdrawn at any time without prejudice to the lawfulness of the processing carried out on the basis of consent prior to its withdrawal.
      4. The data will be processed for the purposes stated above and until this consent is withdrawn, and access to the data will be granted only to selected persons who are duly authorised to process it.
      5. Any person providing personal data shall have the right of access to and rectification, erasure, restriction of processing, the right to object to the processing and to the transfer of data, the right to restriction of processing and the right to object to the processing, the right to data transfer.
      6. Every person whose data is processed has the right to lodge a complaint with the supervisory authority, which is the President of the Personal Data Protection Office (ul. Stawki 2, 00-193 Warsaw).
      7. Personal data may be made available to other entities from the group that SNP Poland Sp. z o.o. is part of – also located outside the European Economic Area, for marketing purposes. SNP Poland ensures that the data provided to these entities is properly secured, and the person whose data is processed has the right to obtain a copy of the data provided and information on the location of the data provision.

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