Third Party Inspection And Quality Assurance Services

TCR Engineering Services from its offices in Mumbai provides control and quality assurance services to help retailers, trading partners, importers and manufacturers assess product quality and meet the regulatory requirements of the industry vertical.

Independent quality assurance services of third TCR results in improving product quality, with a reduction in customer complaints, noncompliance and product recalls.

Equipment deployment TCR staff can also provide qualified NDT personnel for their projects control contracts with strong experience on the site and offshore.

The inspection team at the site covers all states of India. The pricing structure for services on-site inspection is set competitively and is based on man-day charges.

Our inspection services include:

Factory Audit
Service TCR Engineering Services Factory Audit verifies the ability of a manufacturer to meet contract conditions for terms of quality, quantity and delivery. These assessments are often tailor-made according to customer needs and requirements. By using this service, we eliminate the need for a client to be present at the site of the plant or factory of the manufacturer.

OEM Development
TCR Engineering Services with 32 years experience with a team possessing a strong engineering background. This team is ready to provide consultation on the basis of the latest technological advances, incorporating standards and existing national and international standards. TCR can help assist in the creation of a first prototype production, technical documentation, evaluation standards, establishing production and quality criteria and technical transfer to the supplier.

Collecting samples and the analysis of Coordination
Our inspectors can select a predetermined number of samples of the production in a factory and seal, label and send them to our material testing laboratory for testing according to customer needs. In the laboratory materials testing TCR Engineering Services, provide mechanical testing, chemical analysis, Positive Material Identification (PMI), Non Destructive Testing, Metallography, Corrosion Testing, Failure Analysis, Raw Material Inspection, Metallurgical Product evaluation, Engineering Research and Consulting.

Initial Production Inspection
The inspection of TCR Engineering Services can perform a visual inspection of products as available at the beginning of the production cycle against a client's instructions and Purchase Order specifications. The "Initial Production Inspection" when combined with a "Final Random Inspection" and other controls production line, helps in taking corrective action at an early stage of the production cycle. The inspection team will send progress reports to the client and keep them informed on the progress of production in relation to the delivery terms.

Production within Check
The inspection team performs a visual inspection of products throughout the production. The inspection team may subject some products for random testing materials. Service check-in production helps reduce the risk of failure Final random inspection.

Random inspection
Equipment inspection services TCR Engineering Services performs a final random inspection comprising of a detailed visual inspection of goods before shipment. It usually takes place on the premises of the manufacturer, on samples selected according to defined sampling procedures. The inspection criteria covering quality, quantity, marking and packing are based on customer specifications and reference samples, as expected. At the end of the final random inspection a detailed inspection report to the client and the inspection certificate issued to the supplier if all results are positive is sent.

Random inspection can be chosen as a standalone service or a stricter review of the production, service random inspection may be carried out in conjunction with the "initial check of production" and "In-Production checks." Following this inspection, a Certificate of Inspection TCR Engineering Services certifying product quality issue.

Loading Supervision
to further manage the delivery of the products, the inspection team TCR Engineering Services offers Loading Supervision which involves "the case," checking the container condition, identification of the loaded packing units with shipping previously inspected, counting the total number of shipping units and sealed packaging container. Service Loading Supervision is offered in conjunction with the Final Random Inspection.

USFDA Finds Quality Testing Flaws At Wockhardt’s Illinois Plant

FDA said unit of plant quality does not have documented procedures and some systems were not followed

Irregularities in testing similar products were also cited two warning letters issued to prohibited plants and Wockhardt in Chikalthana Waluj in Aurangabad, India. Photo: Kedar Bhat / Mint




Wockhardt Ltd, the manufacturer of generic drugs has faced quality problems at two of its plants in India, was quoted by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois.
FDA issued a Form 483 listing possible violations of the Act Food Drug and Cosmetic Act after inspecting facilities for drug Wochardt in Morton Grove, Illinois, more than 17 days between January and March, according to a document on the website of the agency.

Two of the facilities of the Indian drug maker based in Mumbai and are prohibited from exporting to the U.S. after FDA inspections reported similar violations. If Wockhardt ignores problems, recent observations could affect the company's offerings to its biggest market.

The facility generates more than half of Wockhardt's U.S. sales last quarter. U.S. Business Wockhardt fell 26% in the year ended March 2014 following the import restriction on the other two factories. The contribution of U.S. sales dropped to 45% of total revenue 51% last year.

Form 483, issued on March 26 and contains 12 observations, that unit of plant quality does not have documented procedures and some systems were not followed.

The Wockhardt factory in Illinois is the latest installment in India under scrutiny by the FDA. Four factories of India Ranbaxy Laboratories Ltd are prohibited from selling to the U.S. and this year the FDA put import restrictions on a plant Sun Pharmaceutical Industries Ltd.

Drug Testing

The document cited the specific practice of testing test and said the company has not established appropriate procedures designed to ensure that products conform to appropriate standards of identity, strength, quality and purity.

Irregularities in testing similar products were also cited two warning letters issued to prohibited facilities Wockhardt in Chikalthana and Waluj in Aurangabad, India, the document says, leading the agency to believe that the unity of quality business is not fully monitoring systems in their plants.

The FDA also cited evidence RAW data files that could be accessed and removed by anyone, and workers not trained in good manufacturing practices today.

"It's hard to say what kind of position will make the FDA," said managing director Murtaza Khorakiwala on 27 May call with analysts, referring to the last inspection. "But I think that, in our opinion, the inspection was not-I mean, it was not a negative inspection." Dominic D'Souza, a spokesman for Wockhardt in Mumbai, declined to comment Tuesday on the FDA document.

India To Up Drug Inspection Efforts To Address Quality, Regulation Concerns

MUMBAI (Reuters) - India will spend 30 billion rupees ($ 511 million) and double the number of drug inspectors in the next three years to meet the standards of global manufacturing, said the country's health regulator on Wednesday.



A number of import bans imposed by the Food and Drug Administration U.S. in major generic drug manufacturers in India due to failures in the processes of production in recent years have given rise to concerns about the quality of the drugs sold in other markets, particularly in India.

The government of India the number of inspectors from the Organization of Central Drug Standard Control (CDSCO) 500 1000 now, Drug Controller General of India will increase GN Singh said in a statement Wednesday.

The number of officials from state departments of regulation was increased to 3,000 from 800 now, he said.


“Reference System India (for drug testing and intellectual property) will be at par with global standards the most important two or three years and will even match the U.S. in three to five years," Singh said.

In India, the states regulate the manufacture and distribution of drugs, while CDSCO, which is the federal authority, is responsible for approvals of new drugs and clinical trials, drug imports oversees and coordinates the activities of state regulators.

The chronic shortage of inspectors has made it difficult for regulators to monitor Indian factories over 10 thousand drug manufacturing in India, catering to more than 200 countries.

Multiple state drug regulators told Reuters in April that the skeleton staff and the lack of sufficient drug testing laboratories had surrendered their departments equipped to carry out their duties.