Batch Procedures in Pharmaceutical Industry

A batch is a specific quantity of an intermediate required having a uniform character and quality. This quantity should be in particular limits and should be created during same cycle of manufacture. A batch may be a specific quantity of material or API ( Active Pharmaceutical Ingredient) processed in one or more processes so as to retain the homogeneity.

Biophar Group is a pharma franchise which says that batch number is a precise description printed on the brand of a drug or medicine that locates the batch and lets the production or manufacturing history of batch with all stages of manufacturing and  quality checks which has to be assessed.

 Batch number can also be termed as a lot number. The third party manufacturing further adds that it all starts from the inception of manufacturing process. These batches are maintained according to quantity in relates to the manufacturing cycle with manufacturing and expiry dates and composition of ingredients. The importance of batch number can be very well understood through manufacturing of drugs like capsules, tablets and syrup. The company gives strong weightage in the conduct of drug manufacturing and says that all the medicine can be traced through batch number.  This facilitates checking the content of the drug through their batch number.

According to regulatory requirements each batch of a drug is given a unique identifying number which is written on the batch record . This is helpful in the entire manufacturing process and also in the packaging.When batch of a specific drug like capsule or tablet is finished, then all equipment used for the manufacturing must be cleaned as per the regulatory conditions.  This avoids any contamination in the manufacturing process of further products.

Batch number also helps checking the manufacturing and expiry dates of medicine. It also helps checking the prices of a drug as per the specific batch number and also if there are any  price changes.

Importance of Drug and Medicine Regulation in Pharmaceutical

The regulatory issues in the Indian pharmaceutical industry are of prime importance. Understanding the regulatory scenario in this sector is extremely important for not only because of the rapid and ongoing changes at the globally and strong emphasis on good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP) but also because  responsibility on the regulatory bodies to ascertain a healthy supply of drugs at economical prices to the consumers.

A Drug is a specific substance recognized and located by an official Pharmacopeia and Formulary and used for rehabilitating, recognize, treatment and prevention of any kind of disease or disorder. Therefore, Regulation of Drugs and medicine is very much important keeping the public safety and health on primacy and is done by checking and scrutinizing the quality, efficiency and safety of drugs.

Biophar is a top pharma franchise company which vocalizes that medicine should be manufactured, prepared, stored and distributed under certain rules and regulations. So as to facilitate quality manufacturing organizations like Food and Drug Administration (FDA) has forbidden illegal and unethical manufacturing practices of drugs and medicines. The regulation of medicines is a very important and continuous process that needs to be followed. Certain factors like use of raw material, authentic formulas application, batch number maintenance, timely temperature check , humidity and light control, storage of medicine in appropriate packs, storage under standard conditions, adhering to procedures in the right manner, use of legal documents for maintaining the batch numbers, are some of the important  conditions that are must for regulation of drugs.

The third-party manufacturing further adds that national governments are responsible for establishing strong national medicines regulatory authorities with clear vision, solid legal basis, practical objectives, appropriate organizational structure, and an ample number of qualified staff, sustainable financing, and access to latest technical literature, equipment and information for regulation of drugs. These authorities on regular basis confirm and check the working of quality control department of manufacturers and distributors for using technical literature and information in right direction.

To foster the same strict regulatory plans, implementation and legal documentation are made. The compliance of these regulatory guidelines will have quality manufacturing.

Significance of Particle Size for Pharmaceutical Industry

The science of small particles is known as ‘micromeritics’ and it is widely used in many different industries, including pharmaceuticals.  When we talk about how important the consistency of a drug is for it to work well, the relevance of micromeritics plays very significant role. It is crucial to know that pharmaceutical products are used for endless reasons to cure illnesses, injuries and diseases and if the calculations don’t work the results could be miserable and adverse. Particle size is one of the critical elements in making sure all pharmaceuticals perform well.

Biophar Group is a third party manufacturing which further adds that the particle size of the Active Pharmaceutical ingredient (API)  and diluents need to be evaluated before preparing and designing of drug delivery system as it influences the procedure ,process, stability and efficiency of drug delivery system.

A pharmacist needs to be well educated about particle size and surface area before prescribing a drug to a consumer. Every composition needs to be thoughtfully applied as for example increasing the surface area of the drug by creating finer particles will operatively weaken the physical barriers to dissolution.  This means that the release of the drug happens much quicker because the fine particles dissolve quickly and easily and give results in short period of time.

The third party manufacturing company further adds that knowing the particle size, the release and dissolution and effectiveness of any drug is an important and crucial part of the process and must not be ignored by any pharmaceutical industry.

Overall physical stability of drug is another factor affected by the particle size.  The physical stability of drugs is equally important because it helps to keep the drugs in their intended form, and plays a vital role during manufacturing, packaging, exporting and storage.  Physical stability is yet another factor which affects the particle size because not all pharmaceutical products or drugs are used the same day they are produced, therefore all manufacturers should be very considerate about fact that the physical stability factor must remain unharmed from the beginning of the process till the end.

Projection of Indian Pharmaceutical Industry

The Indian pharmaceutical sector has a strong hold in the market with 3.1 – 3.6 per cent of the global pharmaceutical industry in terms of its value and 10 per cent in its volume and is expected to rise at a Compound Annual Growth Rate (CAGR) of 15.92 per cent to US$ 55 billion by the year 2020 from US$ 20 billion in 2015. India contributes the second largest share of pharmaceutical and biotech workforce in the world.

Biophar Group is a third party manufacturing which further adds that Indian drugs are exported to more than 200 countries in the world, with the US as one of the major market.  In Addition generic drugs hold a share of 20 percent globally in terms of volume and are a supplier of generic medicines globally. It is been said that the numbers are expected to rise in the times to come. India exported pharmaceutical items worth US$ 16.64 billion in this fiscal year.

Some of the key points which highlight the market scenario are:-

• The per capita sales of the pharmaceutical products offer a plethora of opportunities to    the   pharmaceutical companies.

• The economic prosperity would make the generic drugs more affordable which would further accelerate the per capita sales of the pharmaceutical industry.

• The cost of production is relatively 33% lower in India as compared to the US. 

• Like the cost of production, the labour cost is also relatively lower by 50-55 percent as compared to western countries.

• The Production costs in relates to setting up a new plant is also relatively cheaper by 40% 

• The number of skilled workforce with technical and managerial competency in India is much higher as compared to other Asian countries. 

• Indian pharmaceutical industry has strong hold outside the US market. It is the 2nd largest in number of USFDA-approved manufacturing plants.

• The number of FDA approved drugs is also very high with 2633 in number.

• India has more than 546 USFDA-approved company sites, outside the US. 

The Pharma Franchise ponders that the Government of India is taking strong initiatives and plans to set up a US$ 640 million venture capital fund to enhance the research and development of pharmaceutical industry and also upscale and uplift the pharmaceutical infrastructure.

The government plan to make India a major hub for the pharmaceutical industry for the complete research and development, manufacturing and exporting of medicines and drugs by the year 2020.

Packaging and Labeling Speaks About Drug Quality

Pharmaceutical packaging is the art of packaging various pharmaceutical products and adhering to packaging processes for pharmaceutical preparations. It is a process which involves the entire production cycle of a pharmaceutical industry starting from operations till distribution channels to the end consumer.

It is highly regulated with some variation in the details, depending on the geographical location.  There are certain factors which need to be considered while following these processes. Certain considerations like  patient safety, the effectiveness of the drug with relevance to its shelf life, consistency of the drug depending on the production cycle,  detailed and in-depth documentation of all the raw materials and processes, check on the chemical  migrants during  packaging  of components, limit degradation of the drug due to oxygen, moisture, heat, etc., sterility, etc.

Biophar Group is a Pharma Franchise which always adheres to the rules and regulations while packaging their pharmaceutical products so as to protect the properties of their product from the external influences and biological contamination. The company further adds that packaging not only is restricted to safeguarding the quality of the product but also putting the correct information and identification of the product. As per the guidelines of the government, labeling will also include printing of new warnings on the packaging material using red and black color ink only.

The third party manufacturing is a supreme quality manufacturing company which propels that packaging and labeling plays a pivotal role for it not only protects the products from the external environment but also influences the customer buying behavior. Once the packaging is done, it is the responsibility of the company to send that to FDA for approval to check the quality packaging of the product for safety and reliability of the product. Adding further, all the information should be in compliance as per the FDA format. Since the Pharmaceutical industry in India aims to compete globally therefore it is very crucial for them to examine and monitor each and every step taken right from manufacturing to labeling.

Impact of GST on Pharmaceutical Industry

Biophar group is one of the primitive pharmaceutical industry which manufactures quality pharmaceutical products in the market. Quality assurance is taken as one of the most imperative practices in the manufacture of pharmaceutical products, as it is the process of vouching for the integrity of products to meet the standard for the proposed use. It serves as an obligation which makes sure manufacturers meet the requirement of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability.  The top Pharma Franchise Company postulates that quality is a benchmark of perfection for the end-user.

The current statistics of Pharmaceutical Industry is currently the 3rd largest in the world in terms of volume and ranks 14th in terms of value. As the population is rapidly increasing, the need for better Healthcare Services is also expanding and preferred. Five percent of the country’s GDP is spent on the Healthcare sector. The country’s healthcare industry has been growing exponentially in last few years, and the Health Ministry targets for the development of new technologies to end the year for treating fatal diseases. So as to bring in more FDI (Foreign Direct Investment) to the country, the Government has also raised the cap.

The passing of the GST (Goods and Services Tax) Bill has grabbed the attention of all the industries including the pharmaceutical industry. GST has a constructive effect on the Healthcare Industry particularly the Pharma sector. It would help the industries by streamlining 8 different taxes into one uniform tax which will ease out the way of doing business in the country, as well as minimizing the effects of manifold taxes that is applied to one product. GST further would provide an aid to the Pharmaceutical companies in rationalizing their supply chain. To add to, GST will reduce the overall cost of technology. Currently, the technical machinery and equipment which are imported into the country by the healthcare sector are very costly. Also, the duty which is levied is not allowed as a tax credit under the present tax regulations. However, with GST this scenario might change. Under GST, duty charged on the import of such equipment and machinery would be allowed as a credit.

As far as the Pharma Industry is concerned the GST legislation will benefit the customers by making health care more affordable. It will further make customers and industry player be in a win-win situation. The pharmaceutical industry would profit from the GST implementation as it would diminish the complexities and various obstacles to the growth of a business.

Good Manufacturing Practices Undertaken By Pharma Franchise

Biophar Life sciences is a Pharma Franchise in Punjab which is a leading manufacturing unit in the pharmaceutical company. The company is known to maintain its quality standards by manufacturing top quality products with an in-house manufacturing unit which is very well equipped with latest machinery. To deliver the same the company focuses on Good manufacturing practice (GMP) which is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

The company is proactively involved in delivering best quality products by following Good Manufacturing Practice complying with all the policies rules and regulations. The PCD Pharma Franchise abandons Poor quality medicines for they are not only a health hazard but a waste of money for both governments and individual consumers. The main risks by following such practices are unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.  Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

The Drug Controller General of India (DCGI) has mandated risk-based inspections for all the Schedule M units in the country following notification for grant of licenses till perpetuity. The Union health ministry had recently notified Drugs and Cosmetics (Tenth Amendment) Rules, 2017 doing away with renewal of licenses for the manufacture, sale and distribution of pharmaceutical products every five years.“These risk-based inspections are meant to ensure that drugmakers comply with GMP notwithstanding the fact that there is now no need to renew a license every five years. Non-compliance to GMP would immediately attract strict penalties under the law and even cancellations based on the severity of the case,”. The manufacturing and sale of licenses, once issued, shall remain valid forever unless suspended or cancelled by the licensing authority. The relevant rules have been amended for this purpose.  Risk-based inspections are based on a checklist issued for the state drug regulators aimed at streamlining uniform inspection procedures across the country related to GMP.  Central Drug Standard Control Organization recently concluded the checklist and tools which are meant to help them and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant.  The Union health ministry is also in the final stages to release a draft guideline towards the enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products. As per the new notification, an inspection of drug manufacturing plants will be conducted by both central and state inspectors every three years to verify compliance with the conditions of license and provisions of the Drugs and Cosmetics Act, 1940. The manufacturers will have to appraise the regulator and apply for a no-objection certificate in case of any minor or major changes made by them in their unit. Aimed at enhancing ease of doing business in India, the government amended rules for manufacturers to grant licenses that will remain valid as long as they comply with GMP.  

A Premier Pharma Franchise Company

Biophar Lifescience is leading PCD Pharma Franchise Company in Chandigarh. It is a pharmaceutical company that deals in pharma manufacturing and PCD Pharma Franchise Business.

A  leading manufacturers and marketers of Pharmaceutical formulations , it is most preferred in the market, due to the ability to manufacture, export and supply a diverse and qualitative range of products which caters to a plethora of products like Injections, Capsules, Tablets, Softgel Capsules, Dry Syrup, Syrup, Facewash, Ointments, Eye Drops, Lotion, Ear Drops, Oral Liquid (Syrup & Suspension), External Liquids, Creams, Betalactum Products, General Products ,Nutraceuticals, Soaps, Shampoo, Oral Sachets & Powders , External Powder. Their goal is to meet bulk requirements of their clients and for that plan of action they have their own independent manufacturing unit with latest and well quipped machines.

The organization is a third party manufacturing which is rapidly growing due to its qualitative and preferred pharmaceutical products in the market. It is a proliferate in growing pharmaceutical formulations manufacturing, marketing, and exports which makes it a rapidly growing company. They believe in manufacturing and marketing of global quality pharmaceutical formulations which are affordable to the Indian masses. So as to meet the quality requirements, they have separate test machines to check the quality of their drugs and chemicals. The company has expanded its reach to virtually every corner of India by continuously adding new distributors and agents all over the nation for its pharmaceutical formulations.  They just don’t want to restrain themselves by just catering to a particular market segment but their constant endeavor is to spread itself at the unrepresented areas. They do this strategically through appointment of new distributors and lend a helping hand in spreading their business at the most remote and isolated areas through appointment of new franchise, distributors, sole distributors and PCD franchise on the monopoly basis in the market. It is quite evident that such approach would definitely make them reach the top in pharmaceutical industry in near future.