/ By Panorama Consulting & Engineering Inc. / Pharmaceutical Industry/ 0 Comments

Process Validation for Pharmaceutical Industry

For the Pharmaceutical industry, validation of processes and equipment is crucial; while the FDA doesn’t necessarily demand one, documented evidence should prove to overcome future mishaps. A Validation Master Plan is a document that outlines the areas and systems that require validation, risk assessment and their consistency in the long run. A VMP is essentially useful during audits as it lays down the strategies implemented by the facility.

Standard Operating Procedures (SOPs), production formulas, detailed documentation batch change Control, experimental reporting systems, analytical documents, reports development, validation protocols and reports are an integral part of validation philosophy.

The documentation provides information related to the ongoing operation of the plant and is used for development or modifications. Validation happens at various levels and is of different types.

Prospective validation

As the term suggests, prospective validation is a pre-planned process. This validation is carried out during the development stage Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. After which an overall assessment is made; if the results are favorable, the process is satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale, e.g. in the preparation of injectable products.

Concurrent validation
Concurrent validation occurs at the normal stage. This validation establishes that a facility and process will perform as they are intended, based on information generated during actual use of the process. It defines how the product will be managed throughout the process. Concurrent validation process is identical to prospective validation.

Retrospective Validation

Retrospective validation is done on systems that have been operating for a while. Generally during this type of validation, a complete validation process isn’t required. Doing a full validation may not be required; since there is proof that the system functions are as required. However, doing nothing may be a risk. Historical data can certainly be used to support validation.
During retrospective validation, it’s advisable that the product be separated and production should be put on hold until the validation process has been completed.

Revalidation

Revalidation is needed to ensure that changes in the process product quality. Revalidation may be divided into two broad categories:

  • Revalidation after any change bearing on product quality.
    Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure bearing on the established product performance characteristics. Every such change requested should be reviewed by a qualified validation group, which will decide whether it is significant enough to justify revalidation and, if so, its extent.
  • Periodic revalidation carried out at scheduled intervals
    Process changes may occur gradually even if experienced operators work correctly according to established methods. Equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.

Before process validation can be started, manufacturing equipment and control instruments must be qualified. All aspects of manufacturing must be validated, including critical services (water, air, nitrogen, power supply, etc.), and supporting operations, such as equipment cleaning and sanitation of premises. Proper training and motivation of personnel are prerequisites to successful validation.

/ By Panorama Consulting & Engineering Inc. / Chemical Industry • Construction Management • Pharmaceutical Industry • Project Management/ 0 Comments

Signs your construction project is headed towards failure

Chemical and Pharmaceutical Plant Construction projects involve high risks and heavy investments. Sometimes a single risk can manage to blowout your project. At other times, a combination of risks will be the reason for your project failure. One or multiple, either can prove to be fatal for the project and company. It is critical to identify project failure sooner and devise solutions before the risks escalate.

Here’s a list of obstacles that could lead to project failure and solutions on how to overcome them.

  1. Schedule overdue – Scheduling is the first step one takes when working on any project. For any successful project, scheduling needs to be on track. Once the train is off track, your project is bound to suffer. Project leaders must ensure that every schedule is being followed devotedly. In case work deviates from the track immediate measures must be taken to cover for lost time.
  2. Team mismanagement – For a project, the team comprises of experts from varied fields. Architects, maintenance engineers, owners, electricians, plumbers etc. are few of the people that work together on the project. Disagreements and conflicting ideas lead to setbacks in your project. The most effective way to handle these holdups is to evaluate ideas and execute the strategies that are most effective.Project management services should be implemented after thorough analysis.
  3. Budget – While being on schedule is important, managing to be on the stipulated budget is imperative. Spending over the budget can lead to major dents in the financial plan. Project leaders must always be on their toes especially when the budget is skirting towards the warning line.Costs for construction projects are high and involve a lot of risks.
  4. Poor communication – Any project is likely to fail with poor communication. Generally, lower level employees are hesitant to report to upper level management leading to delay in project work. Upper level managers consider it irrelevant to inform employees at the lower level. Communication amongst all levels is vital to ensure that the project is functioning smoothly. The project leader should act as the communicator link between all levels.
  5. Inconsistent management – Project leaders must avoid inconsistency in decision making. When minor plans keep changing course, it will be difficult to meet the goals in time. Leaders have to be firm in their decision-making and must have a foresight for the future. Project management services should be implemented to ensure the success of a construction project.

Every project, no matter how big or small, will face problems at every stage. Good leadership and communication is the glue that will stick your project together in times of failure. A healthy working environment for the employees and strategic approach aid in the long run.
Panorama provides complete project management services right from planning to execution. Every step is supervised under the watchful eyes of experts in the field. With Panorama, your construction project is far from the trenches of failure.