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…
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.
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 …
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.
Validation Policy in Pharmaceuticals | Purpose, Scope and Benefits
Validation is one of the main aspects of pharmaceutical quality assurance. It establishes documented proof that facilities, utilities, equipment, processes, cleaning procedures, analytical methods and computerized systems operate in the required way. Validation policies prescribe how the validation process will be managed in the facility while validation reports are applicable to particular syste…
Validation of Electronic Logbooks in Pharmaceutical Manufacturing
Because of the need to enhance efficiency and to minimize data errors and strengthen data integrity, the pharmaceutical sector is currently making the transition from paper-based records to e-systems. This trend is exemplified by the fact that more and more equipment operation logs, cleaning practices records, calibration logs, maintenance records, environmental and utility operation records are…
Handling Unexpected Validation Results in Pharmaceutical Manufacturing
The purpose of validation activities is to provide evidence that pharmaceutical processes, equipment and utilities, computerized systems and cleaning procedures are consistently functioning as they were intended to consistently. In most cases, validation protocols have a clear definition of the acceptance criteria and expected outcome and provide details based on scientific principles and regulat…
How to Draft an Irresistible Response to an FDA 483 Observation
For any pharmaceutical manufacturer, having an open FDA 483 is one of the more difficult situations to experience. The inspection has concluded; the inspector has issued the objectionable conditions, and it is now up to senior management to convince the agency that the company understands the problems and has the capability of being able to fix those issues.
Guidelines for Preparation of Validation Master Plan (VMP)
Validation is among those activities that ensure the quality of pharmaceuticals during their manufacture. Validation guarantees that all equipment, systems, processes and facilities will be able to meet all pre-defined criteria.
