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.
Showing posts with label Quality Assurance. Show all posts
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…
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.
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 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…
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…
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 …
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…
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.
Risk Assessment in Pharmaceuticals | Principles and Applications
Manufacturing pharmaceuticals entails many processes and systems, equipment and personnel activities that can impact the quality of the product and the safety of the consumer. While there are many strong controls in place and validated systems, it is impossible to completely eliminate all risks. The intent of pharmaceutical quality systems is to not remove every possible risk, but instead identif…
CAPA Effectiveness Evaluation Methods in Pharmaceuticals
The Corrective and Preventive Actions (CAPA) System is a critical aspect of managing the quality of pharmaceuticals. At the same time, CAPA is an important element to assist companies to evaluate deviations, find the root cause(s), corrective actions implemented, and prevent the occurrence of quality issues. However, just because a company implemented a CAPA, that does not mean the CAPA was effec…
How to Reduce Manufacturing Costs in Pharmaceutical Industry
The pharmaceutical market is a heavily regulated, highly competitive environment where a small drop in manufacturing cost can mean the difference between profit and loss, long-term sustainability in business between failure and a lack of survival. Increasing prices of raw materials, compliance regulations, labor, energy and equipment maintenance-related costs continue to wreak havoc on global pha…
How to Create a Batch Manufacturing Record (BMR)
An essential document for pharmaceutical manufacturing is the Batch Manufacturing Record (BMR). The BMR contains all the details on how to make a specific batch of product and is a record of evidence that will confirm that the batch was manufactured according to approved procedures. An ideal BMR supports the quality, traceability, consistency and regulatory compliance of the product.
Prospective Validation in Pharmaceuticals | Complete Guide
Validating a pharmaceutical manufacturing operation is an essential aspect of the production of quality pharmaceutical products in accordance with predetermined quality criteria. One of the most essential types of validation is prospective validation, as it provides documented evidence enabling a pharmaceutical company to commence commercial production prior to the commencement of normal commerci…
Qualification of Systems and Equipment in Pharmaceuticals
In the production of pharmaceuticals, there are many steps that must be completed consistently. A small issue with a piece of equipment or the utility system can greatly affect how products are made and cause products to be contaminated or rejected and cause pharma manufacturers to be out of compliance with regulations. For this reason, pharmaceutical manufacturers must complete qualification of …
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.
Revalidation Triggers in Pharmaceuticals | When and Why Required
Pharmaceutical manufacturers must validate their manufacturing processes. It is going to provide proof that a pharmaceutical company's equipment, utilities, systems and processes operate according to proper procedures consistently. Validation may not be a repetitive process and as time goes by your validated condition may be affected by one or more variables, i.e. change, deviation, trends, e…
