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.

What is a Validation Master Plan?

A Validation Master Plan or a VMP is a document that outlines the principles and defines which processes and equipment need to be validated and the order of priority in which the same will be done. Validation of products, processes and facilities is an important part of a company’s Quality Management System(QMS). While the FDA doesn’t necessarily require a Validation Master Plan, it is often included in quality engineering services.A VMP should have logical reasoning for including or excluding every system associated with a validation project based on a risk assessment.
Pharmaceutical, biotechnology and medical device manufacturers are the key sectors that require a VMP. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects.
The VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.The VMP is crucial from a quality and regulatory-compliance standpoint. At times, FDA inspectors may request documentation outlining an organization’s process and equipment validation plan. Thus, VMPs may help companies overcome challenges.

VMPs should include details of:

  • All prospective, concurrent, retrospective validation and revalidation activities
  • Time, location, priority and order of validation activities
  • A statement describing the validation policy of the company
  • An overview of the organization’s scope of operations, describing the facilities, products and processes
  • Facility management/personnel who have agreed upon the plan
  • Details or copies of any corresponding validation plans, existing SOPs, relevant policy documents and validation reports/protocols, etc.
  • Persons who are responsible and provide approval for SOPs, protocols and the VMP, as well as any review and reference tracking systems
  • References to or appendices detailing any plans for validation training programs.

Developing and implementing a VMP offers numerous benefits to manufacturers. A VMP is documented evidence that the manufacturer follows a well-defined strategy and has their validation process under control. This can be essentially useful during a quality system inspection. The VMP can also enhance business efficiency by preventing product or process failures and improving productivity.
VMP also leads to simplification of the validation process. VMP defines validation strategy and requirements, risk management and implementation. Thus, making the validation process simpler.
Operational excellence also benefits from VMP. A holistic approach helps define how the process will be integrated, how risk management will be applied and how validation will be handled for continuous improvement. It also defines how validation will be performed throughout the project life cycle and through regulatory submissions and other phased approval.
While the need of a VMP is not specifically required, it has become common practice in the pharmaceutical industry. The overall objective of a VMP is to ensure that quality requirements for processes and equipment are consistently met. When applied holistically, a VMP will simplify and standardize validation processes, facilitate continuous improvement and operational excellence, ensure smooth integration into quality systems, support design control and the device life cycle, and improve the overall cost of quality.
In conclusion, Validation is an excellent way to minimize risk and maximize production efficiency and quality. The extra cost incurred for validation is directly proportional to the level of risk aversion. Thus, a suitable validation program devised on pharmaceutical manufacturing standards would help build stability and efficiency.

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.

6 simple marketing steps for your Chemical/Pharma Industry

Who says good projects don’t require marketing? Good project deserves intelligent marketing. However, there are many risks involved in marketing especially for a first timer. To achieve genuine success, one must take risks and move out of their comfort zones. Constructing a marketing plan is easy but constructing one that will effectively help your business grow requires critical thinking and strategy. It is important to understand the steps required to create and implement a plan. Any marketing strategy must be well articulated and thoroughly analyzed.

The process to attain the right kind of marketing is long and tiresome; we’ve narrowed it down for you. Here are six points to keep in mind for effective marketing communication.

  1. Small budget
    Just like your construction budget, compute a marketing budget. Don’t be exorbitant start small. Formulate a budget keeping in mind your revenue, marketing plan and competition. Don’t spend too much or too little. Setting a budget will give you a much clear picture on what you’re willing to invest in.
  2. Know your audience
    Conduct client experience surveys in the middle of your project. Obtain feedback from old clients. Testimonials make for great advertising. Not only will this help with prospective clients but can also aid in providing better services and recovering from any problems. Client surveys are helpful, especially, for residential projects.
  3. Core Idea
    Have one central idea. Every brand in the market stands for a value. List down the qualities you want your brand to be known for. Think of your brand as a person and associate it with a personality. Your brand must have a holistic approach. Exploit this core idea in all your marketing collaterals thereafter.
  4. Be creative
    Construction can be fun too. Just as you provide project management services, hire a team of marketing professionals that will guide you through this process. Nobody knows better than an expert. Allow them to take the risks and explore the creative elements hidden in your project. The ultimate goal should be to stand out and be different.
  5. Digital Marketing
    Go digital! The first step in the digital stage is to develop a website. Then you move on to social media. Not only is this a great place to connect with prospective clients but also helps you stay in touch with the old ones. Give your clients a platform to share their experiences.
  6. Monitor the results
    Your marketing plan may be brilliant but it is always better to make sure your efforts are being paid off. Once your marketing campaign kicks off, check whether the campaign is working with the audience or not. Monitor feedback, check statistics, and compare results from previous years.

You may be the best in your field but competition is always running alongside. In this day, making your brand known is vital. The right kind of marketing will help you reach there. However, it is vital to steer clear of the risks that come along with marketing. A well-constructed and thoughtful marketing plan will assist your business in markets with a competitive edge.