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Regulatory

Mccoy Pharma is a WHO GMP certified company and has ISO 9001:2008 certification

Right from its inception Mccoy Pharma’s objective remained to provide drugs of the highest quality and purity for the common man that is zealously persuade till date. ‘Excellence in quality’ is a commitment and the entire staff is dedicated towards this common goal. The quality did not start but was there from the beginning of the unit when the FDA, India, granted the GMP certificate. The regulatory body in India has the most stringent laws comparable to any international body and is fairly similar to the US FDA. As a result from the continued efforts to upgrade the existing facility and technology with much hard work, the company’s major achievement was when it was granted the WHO GMP certificate for 99 products. We proud our self to be among the best generic and branded generics companies in India for the quality product we produce. At Mccoy Pharma where our slogan long stands as " Quality not just a regulation, but a lifestyle", is believed and followed by every person working for the company.

Mccoy Pharma is situated in an approved industrial area known as Modern Industrial Estate at Bahadurgarh, located on the periphery of Delhi. The location is ideal and hygienic approached to the main highway and in the pollution free environment. The factory premises is away from open sewage, drains and from other factories which produces disagreeable odour, fumes, large quantity of soot, dust and smoke.

In keeping with the needs of the time, the venture is totally eco and environment friendly. The manufacturing process is being disposed off as per the industrial norms and guidelines. Strict compliance to the rules and regulations set forth by the pollution control board are being adhered to. Mccoy Pharma looks for the stronger support of its people to adhere to cGMP requirements. Mccoy Pharma is continuously upgrading its facility not only in quality but also its management & administration control.

Quality Control

The lifeline of the company and strength to recon with, we believe that “He who has the most stringent quality control will have the best product”. The company has a self-s ufficient laboratory in place and have some most dedicated personnel’s who are highly motivated to lead this organization. Apart from the Pharmacopoeia requirements the laboratory is equipped to conduct various tests that are required to make a quality product. Capability to identify the impurities and to study the degradation of the products helps to improve the product quality and improves the general understanding of the products.

Quality Assurance

Mccoy Pharma has ever since strived to improve its existing facility by carrying out regular inspection and updating of technology for its products and processes and thus adhere to cGMP. To ensure that the cGMP standards are met and products comply with international quality standards, quality control measures having been imbibed at various stages of productions-from approval of raw materials to goods in-process as well as monitoring of the manufacturing process and extends up-to checking of finished goods. Quality assurance in the production is adhered by strict in-process controls and by validation and optimization of the process to improve quality and production.

CAPA: Corrective and Preventive actions

The company has in place a complete written program under CAPA and the procedure is well defined

Mccoy Pharma under CAPA is analyzing processes, work operations, quality audit reports, quality records, service records complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product and other quality problems. Appropriate statistical methodology is employed where necessary to detect recurring quality problems.

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Investigation is done for the cause of nonconformities relating to product, processes and the quality system.

Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems.

Verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product.

Recording changes in methods and procedures needed to correct and prevent identified quality problems.

Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product for the prevention of such problems.

Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

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