Data integrity has become the new ‘hot topic’ for medicines inspectorates and consequently an important matter for pharmaceutical manufacturers to address in order to meet Good Manufacturing Practice (GMP) regulations.
Data integrity covers a number of areas, including computer systems and manual records. Data must be held securely and must not be open to manipulating, as well as being accurate. According to the European standards, examples include having access to clocks for recording timed events; having documentation in appropriate places so information can be recorded at the time that an event takes place, rather than memorized; audit trails for computer systems; and having supervisors inspect raw data rather simply looking at summary reports.
With the recent warning letter, the FDA inspected three manufacturing plants operated by Ipca Laboratories. Each plant, the website RAPS reports, raised concerns about the validity of the data presented, and this has led to all three sites being banned from sending products to the U.S.
The FDA noted “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh. This included “actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs.” This raised questions about the reliability of laboratory tests used to release pharmaceutical products.
At a separate site, located at Pithampur, the FDA noted that company had “no way to ensure that the tests you use to evaluate the quality of incoming raw materials are accurate or reliable.” This is important since controls on incoming raw materials can sometimes be inadequate, and some producers of raw materials do not manufacture the products to pharmaceutical standards (for instance, materials might be merely food grade.) Bigger risks relate to materials of vegetable origin.
This related to the company not having audited its suppliers of materials, as well as not having adequate laboratory controls in place. There were also concerns about the training and qualifications of supervisory staff.
A number of pharmaceutical companies in India have received warning letters and import bans from both U.S. and European regulators. Last year Digital Journal published a special report titled “Global drug imports from India need better standards.” Here we reviewed the uphill struggle faced by many India pharmaceutical companies to achieve compliance.
