Quality Assurance

QUALITY ASSUARANCE:

 

Quality assurance is an organized department in Deeplaid Pharmaco ltd Which deals with ensuring the quality of the product up to the end user. In 1980s the approach for assuring product quality extended the responsibilities of quality control far beyond the area of testing and compliance check, and the concept of quality assurance was developed:

 

QA= Product design + GMP + QC + Quality goal activities

 

The task of quality assurance are as follows:

 

  • Validation of source
  • Checking of dispensing all production area
  • Product sampling, release
  • Product complain handling
  • Supplier’s performance review
  • Conducting quality audit
  • Perform all type of validation activities
  • Document preparation, editing, control etc.
  • Retention sample collection, archiving, monitoring, retrieval etc.
  • Product quality review (Annual/ Periodic)
  • Artwork preparation, checking, finalization for packing material
  • Preparation of certificate of analysis for finished formulation
  • Establishing manufacturing methods and SOPs covering entire operations and their regular up-dating
  • Communication of every aspects relating to quality to all relevant persons for early positive action
  • Ensuring product stability
  • Ensuring adequate training program

 

Quality Control Department:

 

Quality control department makes all types of Raw materials (Herbs, Chemicals) and finished product analysis find the result in terms of presence, identity, stability etc. The persons working here are responsible for the quality of the products. This is actually the analytical part of the plant.

 

Activities of Quality Control Department:

 

à        Sampling:

             A quality control officer does it when raw materials (Herbs & Chemicals) arrive       

             in warehouse.

à        Analysis:

The Quality Control Officer analyses the sample according to the BP, USP, BHP,  BNUF.

 

à        Checking:

      After the tests, the results are interpreted.

 

à        Final approval: The Q.C manager verifies the result.

 

à        Collection:

                       A Q.A officer collects the results of the sample that was assigned previously.

 

Major Equipment Description:

 

The Duct type A.C system covering this area is controlled by window  unit.

 

Name of Machineries

Country of Origin

Binocular Biological Microscope

BOECO, Germany

Leak Test Machine

            -

Moisture Analyzer

OHAUS, Switzerland

Friability Machine

            -

Dissolution Machine

GUOMING, China

U-V Spectrophotometer

HITACHI, Japan

Analytical Balance-3 digit

SHIMADZU, Japan

Disintegration Machine

            -

P­­ Meter

HANNA, China

Melting Point Machine

SUNSIM, India

Thermostatic Water Bath

China

Digital Oven

England

Conductivity Meter

BOECO, Germany

Incubator

MMM, Germany

Muffle Furnace

Germany

Microscope

Germany

 

Working Division of Quality Control Department:

  1. Analytical Section
  2. Microbiology section
  3. Packing section

 

a)      Analytical section:

Analytical section of Quality Control Department performs analytical tests. Analytical tests are      mainly of two types as follows:

  1. Quantitave
  2. Qualitative

 

 

Analytical activities:

    • Quality builds up and checks
    • Disintegration & dissolution test
    • Friability & thickness test
    • PH test
    • Stability test

 

Stability Study:

 

Mainly for finished products,             Quality Control Department Performs stability study. Aim of this study is to ensure that all batches of the released products are maintaining within specification limits throughout their entire shelf life.

 

Microbiology section:

 

Microbiology section of Q.C department is performed microbiological test. Microbiological tests cover two types of test. One is microbial limit test and another is bioassay of antibiotics.

 

Activities of microbiological section:

  • Microbial limit test of raw materials and finished products
  1. Total aerobic bacteria and fungal count
  2. 2.      Detection of pathogens like; Salmonella sp, Escherichia coli (E.coli)

                                                   Pseudomonas aeruginosa, Staphyococcus aureus.

  • Microbial assay of raw materials and finished products
  • Environment monitoring