Recent Posts

1

Product Quality Testimonies / Phosphorus

« Last post by Sadia Afrin Mou on October 22, 2024, 03:51:43 PM »

Phosphorus plays role in development of skeletal tissue, bone & teeth. Also helps in cellular metabolism.
Calcium: Essential component for strengthening bone & skeleton. Ensure muscle contraction and blood coagulation. Keeps the immune system active.
Vitamin D3: Ensures Calcium absorption & homeostasis.
Vitamin B12: Synthesizes red blood cell and ensures the integrity of nervous system

2

GMP Compliance / What is GMP

« Last post by Nadi on April 17, 2024, 03:37:09 PM »

Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

3

Heart attack / Heat Wave

« Last post by Sadia Afrin Mou on April 17, 2024, 03:27:51 PM »

"Heat Wave" আসিতেছে?
----------------------------------
তাই সাবধান হোন।
সম্ভবতঃ ৪০°-৫০° সে.।
--------------------------------
স্বভাবিক পানি পান করুন।
ধীরে ধীরে।
ঠান্ডা পানি পান পরিহার করুন।
বরফ/বরফ পানি পুরোপুরিই পরিহার করুন।

বর্তমানে মালয়েশিয়া, ইন্দোনেশিয়া, সিঙ্গাপুরে এই  HEAT WAVE চলছে।

করণীয় ও পরিত্যজ্য--------

১) যখন তাপমাত্রা ৪০°সে-এ পৌঁছে তখন খুব ঠান্ডা পানি পান করতে নিষেধ করেন চিকিৎসকগণ। কারণ এতে রক্তনালী হঠাৎই সঙ্কুচিত হয়ে
হঠাৎই স্ট্রোক হতে পারে।

২) যখন বাহিরের তাপমাত্রা ৩৮°সে অতিক্রম করে তখন ঘরে চলে আসুন বা ছায়ায় অবস্থান করুন। ঠান্ডা পানি পান করবেন না। স্বভাবিক তাপের পানি পান করুন বা ঈষৎ গরম পানি।
তাও ধীরে ধীরে।

৩)ঘরে এসেই হাত-পা-মুখ ধুবেন না।হাত-মুখ ধোয়ার আগে একটু অপেক্ষা করুন। দেহকে ঘরের তাপের সাথে খাপ খেতে দিন।
অন্ততঃ আধা ঘন্টা অপেক্ষা করুন হাত-মুখ ধোযার আগে বা গোসলের আগে।

৪) অল্প অল্প করে বারে বারে স্বাভাবিক পানি পান করুন।জ্যুস বা এজাতীয় পানিয় পরিহার করুন। স্বাভাবিক শরবত,ডাব বা লবণ পানির শরবত পান করতে পারেন যদি তা আপনার জন্য অন্য কারণে নিষিদ্ধ না হয়ে থাকে।তবে তাও স্বল্প পরিমানে।

★★প্রচন্ড গরমে বা যদি আপনি খুবই ক্লান্ত থাকেন তবে ভুলেও বরফ মিশ্রিত পানি বা ফ্রিজের পানি পান করবেন না,যদিও ওইসময় ঠান্ডা পানি খুব ভালো লাগে।এটা শরীরে প্রশান্তি ভাব এনে দেয়।কিন্তু এতে হঠাৎই দুর্ঘটনা ঘটতে পারে।

নিজে জানুন।
অন্যকে জানান

4

Tips for Healthy Pet / Some general tips for maintaining the health and well-being of your Pet:

« Last post by mostafijur on January 31, 2024, 04:09:18 PM »

Balanced Diet:Feed your pet a well-balanced and species-appropriate diet. Consult your veterinarian for advice on the best food for your pet's age, size, and health condition.

Regular Exercise:Ensure your pet gets regular exercise to maintain a healthy weight and promote overall well-being. The type and amount of exercise depend on your pet's breed, age, and health.

Routine Veterinary Care:Schedule regular check-ups with your veterinarian. This is crucial for preventive care and early detection of potential health issues.

Vaccinations:Keep your pet up-to-date on vaccinations. Vaccinations help prevent various diseases and protect your pet's health.

Dental Care:Practice good dental hygiene by brushing your pet's teeth regularly and providing dental treats or toys. Dental health is essential for overall well-being.

Grooming:Regular grooming, including brushing and bathing, helps maintain your pet's coat and skin health. It also provides an opportunity to check for any abnormalities.

Parasite Prevention:Use preventive measures to protect your pet from fleas, ticks, and worms. Consult your veterinarian for the most appropriate and effective parasite control methods.

Provide Mental Stimulation:Keep your pet mentally stimulated with interactive toys, puzzles, and playtime. Mental stimulation is vital for preventing boredom and behavioral issues.

Safe Environment:Create a safe and comfortable environment for your pet. Remove potential hazards, secure toxic substances, and ensure your pet has a cozy, designated space.

Proper Identification:Ensure your pet has proper identification, such as a collar with an ID tag and a microchip. This helps in case your pet gets lost.

Spaying/Neutering:Consider spaying or neutering your pet to prevent unwanted litters and reduce the risk of certain health issues.

Monitor Weight:Keep an eye on your pet's weight. Obesity can lead to various health problems. Consult your veterinarian for guidance on portion control and a healthy weight range.

Socialization:Socialize your pet from a young age to promote positive behavior and prevent fear or aggression towards other animals and people.

Remember, every pet is unique, so consult with your veterinarian for personalized advice based on your pet's specific needs and characteristics. Regular veterinary check-ups are key to identifying and addressing any health concerns early on.

Collected From:Google Platform

5

Social / Yearly Conference_2023

« Last post by Sadia Afrin Mou on January 31, 2024, 01:43:37 PM »

We extend our warmest congratulations to these outstanding individuals for their relentless pursuit of excellence. This success is a testament to your hard work, resilience, and unwavering dedication.

“Newtec Pharmaceuticals Ltd.”  Annual Sales Conference 2023, towards a new height of success."

6

Pet Care Education / The Ultimate Guide to Pet Care Education

« Last post by Rasel Ali on January 31, 2024, 11:43:43 AM »

Pets are furry (or feathered, or scaled!) members of our families, and just like any family member, they need our love, attention, and proper care. But with so much information out there, it can be tough to know where to start when it comes to pet care education.


Worry not, fellow pet lovers! This comprehensive guide will equip you with the essential knowledge to keep your furry (or feathered, or scaled!) friends happy and healthy for years to come.

1. Know Your Species

Every type of pet has its own unique needs. Dogs need plenty of exercise, while cats are content with lounging around the house. Guinea pigs require specific dietary needs, while fish need the right water temperature and filtration system. Before welcoming a pet into your home, research their specific care requirements to ensure you can provide them with the best possible life.

2. Veterinary Care is Key

Regular vet checkups are essential for preventive care and early detection of potential health problems. Your veterinarian can provide vaccinations, parasite control, and advice on nutrition, behavior, and more. Don't wait until your pet is sick to take them to the vet – regular checkups are an investment in their long-term health and happiness.

3. Nutrition Matters

Just like us, pets need a balanced diet to stay healthy. Choose high-quality pet food that is appropriate for your pet's age, breed, and activity level. Avoid table scraps, as human food can be unhealthy for pets. If you're unsure about what to feed your pet, talk to your veterinarian.

4. Exercise is Essential

Physical activity is just as important for pets as it is for humans. Regular exercise helps keep pets at a healthy weight, prevents boredom, and improves their overall well-being. The amount of exercise your pet needs will vary depending on their species, age, and health. A brisk walk, a game of fetch, or a romp in the park are all great ways to get your pet moving.

5. Training Makes a Difference

Proper training is essential for all pets, regardless of species. A well-trained pet is a joy to live with, while an untrained pet can be a source of frustration for both you and your furry friend. Start training early and be consistent with your commands. Positive reinforcement methods are usually the most effective, so reward your pet for good behavior.

6. Create a Safe and Stimulating Environment

Your pet's home should be a safe and comfortable place where they can relax and play. Make sure their space is free from hazards, such as electrical cords or toxic plants. Provide them with plenty of toys and activities to keep them entertained, especially if you're away from home for long periods.

7. Shower Them with Love and Attention

Pets thrive on love and attention. Make time to cuddle with your pet, play with them, and simply enjoy their company. Studies have shown that spending time with pets can have numerous benefits for both physical and mental health.

Additional Resources

1. American Veterinary Medical Association: https://www.avma.org/
2. American Kennel Club: https://www.akc.org/
3. The Humane Society of the United States: https://www.humanesociety.org/

By following these tips and doing your research, you can become the best pet owner you can be. Remember, pets are a lifelong commitment, so be prepared to provide them with the love, care, and attention they deserve.

I hope this guide has been helpful! If you have any questions, please feel free to ask.

Happy pet parenting!

Collected from: Google Plaftorm

7

Business Development / Building Effective Business Development in Pharma

« Last post by Rasel Ali on January 13, 2024, 03:59:29 PM »

At a time of rapidly evolving scientific breakthroughs and, coincidentally, of the expiration of many blockbuster drug patents, the key to innovation and revenue growth is pharmaceutical business development. While some innovation and new revenue can come from internal pipelines and assets, business development teams are under intense pressure at most companies to supplement internal efforts with external licensing agreements and M&A. Unfortunately, those teams are frequently unable to deliver the transactions needed for innovation and growth.

Often a major reason for this shortfall is that executive team members are not fully aligned on the role of business development in achieving the company’s strategic priorities. They may agree in theory that business development should pursue partnerships, ecosystems, and collaborations, but that consensus falls apart when it comes to making decisions about specific deals.

We have identified six success factors that enable more rapid and effective decision making, which, in turn, will lead to substantially enhanced business development performance.

Biopharma M&A and Licensing Remain Strong

Biopharma M&A deal value more than doubled between 2017 and 2019, from $138 billion to $336 billion, and valuations reached all-time highs. Most of those deals involved midsized biotech companies, for which the average premium paid was close to 70%, with an average EV/sales multiple of nearly 8x. All in all, close to 60% of new therapeutic drugs in the last five years have been externally sourced.

The COVID-19 pandemic slowed biopharma M&A activity in 2020, especially in the first half of the year. But since the core drivers of deals remain intact—scientific breakthroughs, expiring patents, and an increasing focus on key therapeutic areas or on modalities such as cell and gene therapy—deal activity will continue to rebound. A recent example is AstraZeneca’s acquisition in late December of Alexion for $39 billion.

Moreover, biopharma companies can finance transactions cheaply with today’s very low interest rates. They also have significant financial resources to pursue business development. BCG’s ValueScience team estimates that the top 20 biopharma companies have more than $700 billion in cash, short-term investments, and additional debt capacity. But as a result, many companies are pursuing the same assets, driving up valuations and the risk of overpaying.

Six Success Factors for Pharma Business Development While we focus here on M&A, the six success factors we have identified will enable business development teams to create value through both M&A and licensing. (See Exhibit 1.)

1. Prioritize what business development needs to accomplish for the company. Executive team members often have differing views about how to prioritize business units, technology areas, and technology platforms and what types of deals to pursue (early- versus late-stage R&D deals, for example, or transformative versus tuck-in acquisitions). To ensure alignment, it’s critical that team members agree on how and where they want to create value. Will they use business development to generate near-term revenues or to build the pipeline for future innovation? Will they seek to maximize the core, expand into adjacent markets, or explore new frontiers?

As part of this prioritization process, the executive team needs to regularly review and agree on how much revenue growth the current internal portfolio or pipeline will deliver. Only then can it determine the revenue gaps that business development needs to address in which specific therapeutic areas or modalities—and with what urgency. It’s astonishing how often management teams are misaligned on this simple setting of objectives, which often results in business development teams wasting time assessing opportunities that are fundamentally unattractive to the executive team and will never get approved. To avoid such situations, the team should ask itself two key questions about every transaction early on: What revenue gap will the transaction fill? And who on the executive committee will champion the transaction from start to finish? By forcing these decisions early, the team can avoid a lot of wasted time.

2. Build relationships with prospective targets. Executive teams should commit to building relationships with potential partners or acquisition targets for two or three years. Proactive sourcing, screening, and relationship building are far better for deal execution than simply showing up at the target’s headquarters with a banker and an offer. An established relationship will give a prospective buyer an edge over other bidders, perhaps even preempting the bidding process altogether. Such relationships can also accelerate due diligence.

Active engagement with potential targets over several years also gives companies a better grasp of the range of potential deals available. It might, for example, make a pharmaceutical company more likely to take small equity stakes in a number of promising biotechs, perhaps supporting Phase 1 trials with its own clinical and regulatory expertise.

3. Agree on how to assess value. Depending on one’s assumptions when valuing a target, the same transaction may seem spectacularly attractive or exceptionally unattractive. So teams need to agree about how they will value all aspects of each deal and then apply that valuation with discipline. Too often, companies end up redoing their analysis and engaging in repetitive decision making because they haven’t agreed on valuation approaches or metrics from the start.

One common valuation pitfall is to focus only on core asset value, that is, the value of the cash flow generated by current and future products in the market. Valuation models need a wider lens, encompassing multiple dimensions of value, including the following:

    Synergies. What is the value of cost, revenue, and capability synergies across the value chain—for example, in R&D, manufacturing, and sales?
    Platform Value. What is the value of the future products a technology platform might make possible?
    Strategic Value. What is the value of preempting a competitor from acquiring an asset, gaining access to a large proprietary data set, or being recognized as a leader in an emerging field?

Because these advantages are less tangible than core assets, large swings in valuation are possible depending on the underlying assumptions. We have found that companies with a clearly defined and endorsed valuation approach are able to use a common “language” in their deliberations, leading to better, faster decision making. These advantages are amplified when the company is highly transparent about the underlying assumptions and entertains a range of scenarios and associated probabilities.

4. Define integration issues early. Executive and business development teams are frequently so focused on due diligence and valuation that they don’t consider the integration process until after a term sheet has been signed. Integration issues should be considered at the outset, when assessing the deal’s attractiveness and viability, and in parallel with due diligence. Teams should ask such questions as: Will the acquired company be a distinct entity or be integrated into the acquiring company? What governance will be applied to the acquired assets? How will cost synergies factor into the valuation?

Knowing the answers to these questions early on is critical to realizing the full potential of the transaction. Our research shows that successful integration can drive 8% to 10% more value compared with the average transaction. Planning for that success right from the start is essential.

5. Enable agile business development teaming and governance. Even when a company has a clear vision for the transaction, it still needs an agile process and governance to execute the deal quickly and effectively. But because the business development process is highly cross-functional (and often involves many junior-level people), it can be unclear who has the authority to make decisions and who will provide the necessary analytical resources. In addition, preexisting governance committees (such as executive committees) often meet too infrequently to keep up with the fast pace of business development decision making.

To address these challenges, we recommend three best practices:

    Designate resources. Within each function, several senior staff members with business development experience and authority should be on call. This will help build continuity and organizational learning.

    Establish clear processes and responsibilities. All members of a business development project team should be aligned on processes, deliverables, and timelines. That should include who is responsible for what and who has what decision rights. For example, who in R&D will calculate the probability of success of a specific asset under review?

    Create nimble governance. A few members of key governance committees should meet more frequently than the entire group (perhaps even on a weekly basis, depending on deal volume) and have the authority to mobilize the entire committee within 24 or 48 hours if there’s an urgent issue to be addressed.

6. Design an organizational structure suited to strategic priorities. Because companies have different revenue gaps and objectives and use business development in different ways, there is no single “right” organizational structure. One company might focus on early-stage and another on late-stage acquisitions. One company might be looking for deals to strengthen the core business, another to build up new therapeutic areas. A company’s business development organization must be suited to its strategic purpose, whatever that may be. There are three main approaches (with various permutations) to consider:

    Centralize business development in one group. A central function maximizes scale, alignment of activities, and resource prioritization. This setup works well for companies looking to make relatively few late-stage or transformative acquisitions.
    Separate R&D and commercial transactions. Assessing an early-stage R&D acquisition requires a different mix of expertise than assessing a late-stage, commercial acquisition. When a company intends to pursue both types of transactions, it’s best to keep at least some of these due diligence activities separate. But such companies can still centralize certain functions—valuation modeling, for example—in order to maximize scale.

    Separate by business lines or therapeutic areas. It can be sensible to separate business development activities by business lines or therapeutic areas at different levels of maturity. This arrangement works well if a company has a mature business area looking for transformative deals and a smaller business unit looking for technology platform acquisitions. Here again, certain aspects of the business development process, such as valuation modeling, can be centralized for scale and efficiency.

Current market conditions present unique opportunities to tap into external innovation and drive revenue growth, but the inherently complex and cross-functional nature of business development makes it difficult for many pharmaceutical companies to execute effectively. As a result, these companies are not winning the transactions necessary for future success. We believe that the six success factors described above can significantly improve business development capabilities and are worth serious consideration by management teams.

8

Corporate Social Responsibilities / Corporate Social Responsibility as a Driver for Improved Sustainability

« Last post by LamiyaJannat on May 31, 2021, 01:20:40 PM »

The pharmaceutical industry must respond to growing expectations for product safety, the conduct of clinical trials, access to therapeutic care and the environmental impact of medicinal products and manufacturing. Servier Group formalized its Corporate Social Responsibility (CSR) strategy to integrate and communicate the actions it is taking in collaboration with internal and external stakeholders.

What is CSR?

Corporate social responsibility (CSR) encompasses activities taken by companies, typically those that go beyond legal requirements, to reduce their environmental impact and enhance the social well-being of their employees and members of their communities — and the world. CSR is important as large companies have significant influence over sizable groups of people, from their customer base to politicians, and measurable impact on the environment. With CSR, that influence is used to achieve positive change.

In 2018, many companies are ramping up their activism and investment in issues that impact their employees, customers and communities.1 Some of the areas they are focusing on, according to Susan McPherson, CEO of McPherson Strategies and contributor to Forbes, are workplace harassment and inequality, diversity, privacy and data protection, brand activism, climate resilience and supplier standards.1 She notes: “As 2018 unfolds, it’s likely that companies will continue taking unprecedented action to accelerate social and environmental progress.”

ISO 26000:2010

The International Standards Organization first published ISO 26000 – Social respon-
sibility in 2010.2 This standard consists of a set of voluntary guidelines for implementing a CSR strategy and operating in a socially responsible manner. The goal of the guidance is to help companies understand the principles of CSR and to translate them into programs using best practices. It was developed with input from approximately 500 representatives of various governments, NGOs, companies, consumer groups and labor organizations from around the world.

Why CSR in the Pharma Industry?

It is the manufacturer’s responsibility to ensure all medications are produced at the highest levels of quality and safety, using processes with minimal environmental impact. Workers and communities must be protected and supported, and the medications must be accessible to patients. Although most pharmaceutical companies take these responsibilities very seriously — and despite tremendous advances in the treatment of diseases and the exciting promise of next-generation biologic drugs — public perception of the industry has declined in recent years. CSR strategies provide a clear mechanism by which pharmaceutical companies can demonstrate and communicate their commitment to social and environmental issues.

Source: pharmasalmanac

9

Regulatory & Legal / What is Regulatory Compliance? And Why it is Important in Pharmaceutical, Medica

« Last post by LamiyaJannat on May 31, 2021, 01:12:57 PM »

Understanding regulatory compliance and its importance in the pharmaceutical, medical device and healthcare industries is very crucial for regulatory professionals, and anyone connected with these industries, for a number of reasons.
Firstly, Discussion of Regulatory Compliance:

Regulatory compliance means being in accordance with the regulations set out by regulators. It is being in a state where the regulatory requirements are met to the fullest extent, as required by regulatory agencies. Meeting regulatory requirements is a prime requirement for everyone who is part of an industry that is regulated. These regulations are made by the regulatory agencies across the world, whose intention of making these regulations is to ensure the quality of products that are made by organizations in their industry.

Meeting regulatory compliance requirements is important for businesses in all sectors, but is of critical importance to pharmaceutical, medical devices and healthcare because of the reasons stated below. By complying with regulations set out by regulatory bodies; an organization in the pharmaceutical, medical device and healthcare industries gains the following benefits:
Eliminates Risk:

Another major benefit of compliance with the regulatory requirements is that organizations in the healthcare, pharmaceutical and medical device industries can identify, mitigate and eliminate risk at all stages. Risk elimination is one of the core purposes of regulatory compliance, and is built into the core of all processes. Regulatory agencies spell out clear guidelines on how to identify and mitigate risk. The processes suggested by the regulatory agencies act as ready reference for organizations that manufacture products.

Enhances Customer and Investor Confidence:

No product is likely to gain the trust from everyone who matters, right from the customers, stakeholders, employees and investors alike, unless it has met regulatory compliance requirements. Complying with regulatory requirements is the highest and surest guarantee and safeguard for the efficiency and efficacy of a product. When a pharmaceutical, medical device or healthcare company gains the trust of these vital players, it can be said to be valued company.
Saves Costs:

Yet another benefit compliance with regulatory requirements brings for companies in the pharmaceutical, medical device and healthcare industry is that it helps to save costs throughout the lifecycle of the product. High costs are associated with ensuring compliance, but the cost of noncompliance is multifold higher. If an organization discovers that it has failed to meet regulatory requirements at any particular stage; it is usually impossible to abandon work at that stage and start afresh. The cost is astronomical in such an exercise.

Having said this, it is not possible for such companies to give up their work at that stage, because it renders void and useless all that is done till then, leaving them in a typical Catch-22 situation. Further, products that fail to regulatory requirements cannot pass the test of regulatory approval. If they have to fulfil the penalty requirements of the FDA or other regulatory agencies; the costs spike up no end. So, meeting regulatory compliance requirements at every stage is the safest and most economical option for a company in the pharmaceutical, healthcare or medical devices industries.
There is no alternative to meeting regulatory compliance requirements by pharmaceutical, medical devices and healthcare companies

Given the nature of regulatory compliance, the importance of regulatory compliance to pharmaceutical, medical devices and healthcare becomes clear. All these three industries have much in common, but the most important commonality is that they all play a critical role in ensuring health and wellbeing of people. It is unthinkable how pharmaceutical, medical devices and healthcare can be seen to serve any purpose other than this.

This is where the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood, because no other means ensure the wellbeing and health of people than regulatory compliance. We have just examined how regulatory compliance is essential and indispensable to make sure that the processes and products in these industries meet quality standards. When the products in these industries comply with regulatory requirements, it ensures that they are of high quality standards, which in turn is the sole means to seeing to it that human wellbeing is ensured. It is in this context that the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood.

The main purpose of regulatory agencies around the world, such the FDA, the EMA and others, is to make sure that the pharmaceutical, medical device and healthcare industries deliver the best products to the people who use them. This is never going to be possible unless the companies that make these products adhere to the regulatory compliance requirements set out by these agencies. This is how one can get an idea of the importance of regulatory compliance to pharmaceutical, medical devices and healthcare.

Source: GCPlearning

10

GMP Compliance / How to Sustain GMP Compliance in Your Pharmaceutical Company

« Last post by LamiyaJannat on May 31, 2021, 01:06:56 PM »

The pharmaceutical industry in every country is heavily regulated by central and state authorities. They have developed GMP compliance regulations to enhance the safety of pharmaceutical products and to ensure that patients get only the highest quality of medicines.

Being compliant with GMP regulations is good for your company as well. It drastically reduces the number of batch recalls and decreases the number of adverse reactions reported in patients from different geographical localities. Not to forget, both these facts have direct impact on your reputation.

So what measures can you take to sustain the GMP compliance in your own firm?

Set up a Quality Team

Having a team of skilled workers focused on improving quality and complying with GMP is the building block of your mission to manufacture quality products. Pick up one efficient member from every department including manufacturing, testing, storage and distribution to build a team with diverse experience and knowledge. The members should thoroughly analyse and discuss the problems occurring in routine operations.

Quality Assessment

When the team identifies root cause of any problem, they can decide whether it has the potential to deter the GMP compliance. Their views and results are used as inputs to develop appropriate improvement measures. For example, if the assessment by quality team shows a processing or instrument error that can affect the quality of products, the remedial measures should target to eliminate the error.

Validation Activities

Many employees in pharmaceutical companies still don’t clearly know what validation really is. Well, it’s just a documented act of demonstrating that the instruments, processes and activities used in your firm regularly lead to expected results without any hindrance. Since GMP requires a number of things to be validated, make it an ongoing process focusing on the following aspects:

-    Process validation
-    Cleaning and sanitation validation
-    Computer system validation
-    Analytical method validation

Surprise Audits

An unexpected audit of every department gives you fair idea about what’s going on in the facility and the level of GMP compliance. It helps you identify the real sources of non-compliance. Take appropriate measures to curb the situation before it deteriorate.

Share the findings and solutions with employees in all the departments. Invite them to send their feedback along with new ideas to improve compliance.

Monitor the Performance

Schedule the monitoring of instruments, equipments, processes and staff skills at specific intervals to achieve greater efficiency. Sometimes the employees in production department may be ignoring a problem with an equipment just because it has become a common incident.

Compliance Training

Perhaps the best way to ensure GMP compliance is to provide your staff compliance training, educate them and let them realise the importance of Good Manufacturing Practice. It’s an effective way for pharmaceutical manufacturers, medical device companies and food product firms to ensure the safety and effectiveness of their products.

The employees at work should have received prior training on record-keeping, sanitation, equipment handling, labelling, constant vigilance, Standard Operating Procedures, ways to minimize errors, etc.

Without compliance, all the guidelines, manuals, instructions and principles are worthless. What’s the use of all those rules if you aren’t following them? That won’t yield desired outcomes. So, GMP compliance is an important part of any pharmaceutical firm and its reputation.

Source: gmp7