PHARMA PRODUCTS

We are engaged in Third Party Manufacturing and have several principal Pharmaceutical Manufacturing company's who are winners of several Quality Excellence Awards and are also ISO 9001 Certified. In line with our Philosophy of consistent improvement in quality of our products, our principal company's have set up a state-of-the-art manufacturing facility for meeting the GMP requirements.

Product List:

Methodology

The following are some of the elementary GMP's which are being implemented :

  • Weighing balances and measuring equipments are carefully selected, regularly checked and calibrated.
  • Careful handling of Raw Materials is done to minimize dust generation, thereby prolonging efficiency and filter life and also reducing chances of gross contamination.
  • Through cleaning of processing equipments after their use each time.
  • Making use of carefully written and understood procedures.
  • Making use of clear, concise and well laid documents.
  • Proper labeling of containers, equipments and other items used during processing.
  • Ensuring cleanliness and good house-keeping in the surrounding area of operation.
  • Following clearing procedures with specific attention to critical parts of machines, equipment and packaging lines.
  • Identifying problem areas and addressing them to proper authority with possible solutions, if any.
  • Recording of temperature and relative humidity of the area where the different unit operations are carried out, including storage area.
  • Product labels are distinguished by shape, colour, size and design in order to avoid mix ups.
  • Off lining batch coding, dating and coded labels.
  • Handling different products separately.
  • Avoiding frequent in and out movement of personnel at the workplace.
  • Banning of chewing tobacco, bettlenut, gutkha etc. in manufacturing areas.
  • Ensuring that cleaning equipments such as vacuum Extraction unit, supply of hot and cold water, distilled water, dustbins and preliminary machines tools (such as set of spanners & Screwdrivers) are available at work place.
  • Adequate light and air velocity are maintained in different manufacturing areas.
  • Documents are made available at the relevant places.
  • SOP's (Standard Operating Procedures) are written in English as well as Regional languages, dismantling, assembling and operations clearly written and contains only those information applicable to that particular model of machine. These SOP's are well displayed at workplace after proper frame-work.
Documentation:
  1. All the facts or even untoward observations during manufacturing and packaging area are mentioned in the job card. It is even mentioned in Regional language, so that in case of any complaint, same can be useful to take corrective action and reoccurrence can be avoided.
  2. Different In-process control parameters at each stage is recorded during the processing.
  3. QC sampling and IPQC records are accompanying every batch sheet.
 
Dispatch:
  1. The said batch of product is cleared by QC Dept.
  2. The yield conciliation has been done and per cent losses are within the specified range.
  3. All the documents pertaining to the said batch of the product are complete and signed by appropriate authorities.
  4. The vehicles carrying finished good is clear enough and have necessary full proof protection from rain and dust during transportation.

QUALITY ASSURANCE & QUALITY CONTROL DEPARTMENT

 
These departments act at manufacturing as per design specifications and emphasis on zero-defect products.
 
  • QA is largely directed at meeting goals and preventing adverse change. QA is the activity of providing the evidence needed to establish confidence, among all concerned, that the quality-related activities are being preformed effectively.

  • QC consists of observing actual performance, comparing this performance with same standard, and then taking action of the observed performance is significantly different from the standard.

Validation :

Validation has become mandatory for us to comply with the new regulatory guidelines. It helps us to assure that each batch meets its predetermined specifications, & customer requirements; It also helps to reduce the chance of rework and product recall. It also saves money and time in the long run.

In validating, three Qualification terms are involved :
  1. IQ - Installation Qualification.
  2. OQ- Operational Qualification
  3. PQ - Performance Qualification
The above 3 Q's helps us to clarify the following :
  • The systems and process are validated.
  • The equipment and materials are qualified.
  • People are trained and qualified.
Quality Audits

It is an imperative for enhancing productivity. Audits helps to identify areas of risk and opportunities for improvement as business performance. Quality audit inspection team from several departments are set up to audit work area.

Training

All personnel are trained and indoctrinated in the performance of the tasks to which they are assigned. Training records are maintained and kept up to date to review annually. Employees are rewarded for extra ordinary achievements, contribution or participation in the form of remunerations or recognition.

Employees participation

All personnel are trained and indoctrinated in the performance of the tasks to which they are assigned. Training records are maintained and kept up to date to review annually. Employees are rewarded for extra ordinary achievements, contribution or participation in the form of remunerations or recognition.

Safety programme

Plant safety programme play an important role in quality control since hazardous conditions diminish employee morale and performance.

Safety programme consists of:-
- An active, continuing safety campaign through out the plant including
  1. Posters displayed permanently.
  2. Safety bulletin boards listing recent plant accidents and method of prevention.
  3. Safety inspection teams from several departments to audit work area.
  4. Lectures and movies.
  5. Availability of safety equipments.
    • Identifications of all service lines such as water, gas, vacuum waste, steam electricity communication, including direction of flow.
    • Fire extinguish for all types of fire in each department .
    • In plant alarm, emergency light generators.
    • Emergency teams, including fire and first aid..

We purchase bulk active Ingredients, excipients and packing materials from reputed manufacturing companies. These materials are sampled and send to reputed public testing labs, on the receipt of materials approval, we supply these to our principal companies for manufacturing our required production.

We have qualified and experienced personnel who supervises all the manufacturing process from raw materials stage to finished goods stage. Samples from finished goods are sent to public labs for testing of each and every batch, after receipt of approval, the products are duly pack in export Sea/Air worthy packing and they are duly labeled as desired by the customer.

We personally take care of all the dispatch process like transportation from work to Sea/Air port. Third party inspection, custom clearance upto final dispatch.

We take care of all the quality measures which will give best quality fulfillment and complete satisfaction to our clients as Quality is necessity and the basic feint of our business.