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).

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Regulatory Actions in the Pharmaceutical Industry

The occurrence of regulatory action is one of the most severe consequences that can befall a pharmaceutical company as a result of a regulatory agency discovering serious issues with its production, quality, data integrity, or compliance systems.

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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.

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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…

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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.

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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.

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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.

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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…

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Effective Validation in Pharmaceutical Manufacturing

Validation can be defined as written proof showing that a process system or equipment is working as it was meant to be. In reality, however, successful validation is much more complicated than simply going through the protocol steps and obtaining signatures.

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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.

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Aseptic Manufacturing Process in Pharmaceuticals

Pharmaceutical manufacturing has aseptic production as one of its toughest processes because the end product has to stay sterile without the need of terminal sterilization after filling. This implies that the process must include control of microorganisms and the contamination due to particles at every manufacturing step, starting with the preparation of the components, through the actual filling…

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Gowning Procedure in Sterile Manufacturing

In a sterile manufacturing environment, personnel represent one of the greatest possible causes of contamination. A cleanroom can have a suitable HVAC system in place, good equipment, validated cleaning practices and effective environmental monitoring systems; nevertheless bad working practices can lead to issues with contamination control.

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Validation of Continuous Manufacturing Processes

Continuous manufacturing affects the way processes are developed, certified and validated in the pharmaceutical industry. Instead of manufacturing pharmaceutical products in batches, which means a fixed amount of material produced until it is stopped, continuous manufacturing refers to uninterrupted or semi-constant processing of materials through the interconnected processes involved in the manu…

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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…

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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…

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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…

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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.

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Validation Failure Due to Poor Risk Assessment: Case Study

Validation failures are usually due to improper testing, equipment failure, or mistakes made by the operator. One of the most common causes of validation failures is not mentioned often enough, which is the poor risk assessment done in the planning phase. Inadequate identification and assessment of potential risks can lead to improper validation protocols, which could mean that critical parameter…

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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…

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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.

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Documentation Practices That Impress Inspectors

During an inspection by regulatory authorities, various documentation reveal the working of a pharmaceutical facility. Although inspectors spend only few hours on the production site, they spend days scrutinizing batch reports, logbooks, evaluation documents and quality assurance documents. This documentation indicate whether processes have been implemented correctly and scientific rationale of d…

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Troubleshooting Inconsistent Batch Performance in Pharmaceuticals

The core of pharmaceutical production is the concept of batch consistency. Every batch must conform with all predetermined specifications regarding quality, purity, potency, dissolution, uniformity, and stability of the product. Noncompliance of batches, even if they were produced in the same manner, raises questions regarding the reliability of the manufacturing process and its control over the …

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Inspection Readiness Timeline for GMP Inspections

An inspection carried out according to regulations is one of the major moments in the life of a pharmaceutical production plant. Regardless of whether the inspection is done by FDA, EMA, WHO, MHRA or any other agency, the inspectors will demand a proof that the factory has been working in the compliance mode. They will not be impressed with an industrial facility that has been tidied up and organ…

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Root Cause Analysis of Failed Cleaning Validation: A Practical Guide

One of the hardest experiences that any pharmaceutical company could encounter is the failure of the cleaning validation process. There are negative implications from such a failure relating to product launch, as the failure leads to considerable concerns about the reliability of the cleaning process in terms of the prevention of cross-contamination.

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Utility Design Considerations for Efficient Pharmaceutical Manufacturing

When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or improvement of production methods. But in practice, many reasons of delays in production, quality non-compliance and sudden stoppage are connected with utility systems that is not taken seriously enough.

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Steps to Calculate MACO for Cleaning Validation in Pharmaceuticals

Cleaning validation is one of the most studied and analyzed processes during the pharmaceutical inspections since it demonstrates that the cleaning of production equipment can be performed with high quality and with full assurance that there would be no cross-contamination. While visual inspection of surface cleanliness is crucial, authorities also require companies to define the maximum allowabl…

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Worst-Case Product Selection Using Risk Assessment in Validation

Verification tools are always limited although many pharmaceutical manufacturing sites manufacture various products utilizing the same machines. It is neither sensible nor scientifically acceptable to validate each product separately. In its place, authorities want manufacturers to select typical worst-case products through a documented risk analysis process. If the validation proves that worst-c…

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How to Perform a Mock Audit to Simulate a Regulatory Inspection

Each pharmaceutical producer hopes to successfully emerge from a regulatory inspection, which is not possible just because it wishes to do so. Food and Drug Administration (FDA) inspections, as well as other regulators like MHRA, EMA, WHO are scheduled as surprise or unnotified inspections, which quickly spot shortcomings missed by normal internal audits. The difference between a successful inspe…

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How to Calculate Sampling Size of Raw Materials | n, p and r Plans

When raw materials are delivered to a manufacturing plant, they pose a threat to the quality of finished goods. The quality department cannot presume that every box, even though it comes from a certified supplier, is uniform and pure. This is why sampling plays such a crucial part in GMP compliance.

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Eliminating Dead Legs in Pharmaceutical Piping Systems

The piping systems and water systems are made to carry vital services like PW, WFI, pure steam, process gases and CIP solutions without compromising product quality or microbial safety. However, even the most efficient water systems can present a risk of contamination when stagnant regions inside the piping system appear. The presence of dead legs is one of the main culprits responsible for micro…

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