The occurrence of failures in GMP compliance is often linked to a contribution of multiple weak links rather than being a result of a single occurrence of an error or violation in procedures or SOPs. Rather severe GMP compliance problems normally indicate the presence of deficiencies related to pharmaceutical quality system, defects in management supervision, weaknesses with investigation, data i…
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Out of Trend (OOT) Results in Pharmaceutical Quality Control
An analytical result does not necessarily have to exceed the specification limit in order to warrant concern regarding product quality. In the pharma industry, a result may be comfortably within the specification limits and yet evidence the occurrence of a change.
Such a situation is often referred to as being out of trend (OOT).
Such a situation is often referred to as being out of trend (OOT).
HACCP in Pharmaceutical Manufacturing | A Practical Guide
Hazard Analysis and Critical Control Point, commonly known as HACCP, is a systematic preventive technique for identifying hazards and assuring that they are controlled before they threaten product quality. HACCP was developed for food production but the principles can be equally effective when applied in pharmaceutical manufacturing as part of the Pharmaceutical Quality System.
Regulatory Observations in Pharmaceutical Manufacturing
When regulatory authorities make observations, it signals an indication that the company's systems, processes and controls may not comply with regulatory standards. Observations do not imply necessarily that the company's products are flawed or that quality systems have failed in their entirety. Nonetheless, observations reflect concerns raised by the regulatory authorities that necessita…
Periodic Review in Pharmaceutical GMP Systems
The periodic review is an essential part of a suitable Pharmaceutical Quality System. It allows examining the ongoing processes and understanding if a process, equipment, system, document or validated system still performs according to the requirements.
Calibration Records in Pharmaceutical Manufacturing
Calibration records are critical quality records kept by pharmaceutical manufacturers. A long list of measuring instruments is frequently used in making decisions which can impact product quality.
Pharmaceutical Document Management System Guide
A vast volume of highly regulated data is produced by a drug-producing company on a daily basis. Various documents, such as Standard Operating Procedures (SOPs), specifications, protocols, documents, forms, policies and log books must be maintained in a precise and timely manner ensuring their availability at all times.
Documentation Gaps in Pharmaceutical GMP Systems
Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term is much broader. Properly organized documentation system enables a company to recreate any operations, monitor who performed a specific operation, trace ways of how this operation had been accomplished and assess if and how this operation was done in a valid…
Training Records Management in Pharmaceuticals
At any pharmaceutical production facility, training records serve as proof that an employee has attended a training program. It supports the quality system by showing that the workforce is properly qualified to perform their responsibilities.
Validation Strategy for Contract Manufactured Products
The decision to outsource pharmaceutical manufacturing is an important aspect in the operations of many businesses. Contract Manufacturing Organizations (CMOs) offer extra advantages, such as manufacturing capacity and technological capabilities and allow Marketing Authorization Holders (MAHs) to concentrate on development and commercialization. Nevertheless, it is crucial to keep in mind that re…
Critical Process Parameters (CPP) in Pharmaceuticals
Imagine that a tablet compression machine is correctly functioning as highlighted in the process instruction document. The speed of compression is optimal, the machine is validated and the people running the process are competent. Still, the finished tablets fail the dissolution test. An inquiry reveals that the cause of the issue lay with unnoticed increase in the moisture of granules prior to c…
Failure Mode and Effects Analysis (FMEA) in Pharmaceuticals
The pharmaceutical industry operates on the preventative principle of failures, which means production failures are avoided before they occur and have an impact on product quality or patient safety. While analyzing deviations, complaints and investigations can provide much needed lessons once the event has already taken place, the best quality systems work on the principle of predicting risks and…
Handling Out of Expectation (OOE) Results in Pharmaceuticals
Not every problem with quality in pharmaceutical production is an OOS situation. There are plenty of cases when testing gives results in compliance with specifications but at the same time differing significantly from the past records of results or from expected performance. Such contradictions are known as OOE results.
Validation Report in Pharmaceuticals: A Practical Guide
Validation tests do not finish once the testing phase has been accomplished. A good validation report proves the outcome of the validation process and contains information about what was tested, the method applied for conducting tests, the results obtained and difficulties faced during the tests. The validation report provides written evidence that a facility, a system, equipment, utility, proces…
Best Practices for Reviewing Validation Documents
Validation documents go beyond regulatory documentation; they are written proof that the pharmaceutical premises, equipment, utilities, computerized systems, analytical methods, and manufacturing methods work properly on a permanent basis. Validation document quality establishes, among other things, the trust level of regulatory authorities in the company’s performance and products.
