To lay down the procedure of work organization in the microbiological laboratory.

To lay down the procedure of work organization in the microbiological laboratory.

It is applicable to the work organization in the microbiological laboratory.

PROCEDURE

General items

The main task of the microbiological laboratory is to control the microbiological purity production environment and products during all manufacturing levels.

The microbiological laboratory does analysis of raw material, water, packing materials, finish products, and others as well as monitors the manufacturing environment as per specifications, Pharmacopeia’s monographs, and standard test procedures approved by the company.

Staff responsibilities

The responsibilities of the microbiological laboratory is:

  • Perform duties of the microbiologist job instructions, laboratory, microbiology, respectively.
  • Daily control of devices and equipment, carrying out quality checks of its operating procedures.
  • Carrying out cleaning and disinfection in the premises of the laboratory microbiological analytical methods.
  • Preparation of laboratory glassware, tools, materials, and jobs for research.
  • Preparation of essential nutrient media for growing microorganisms.
  • Sampling for research.
  • Working production documentation.
  • More details about the responsibilities of the staff of the laboratory.

Head of laboratory responsibilities

The  Head of the Laboratory carries out its work in accordance with the current job instruction.

The  Head of Laboratory conducts control over:

  • Carrying out the responsibilities of the laboratory staff.
  • Compliance with production discipline.
  • Compliance with safety, fire, and biological safety when working in the laboratory.
  • Abide by analytical methods in the analysis.
  • On-time conducting laboratory documentation.
  • More details about the responsibilities of the Head of the laboratory look in the procedure..

The Head of the Laboratory performs an integrative role between the quality control department and laboratory staff.

Principles of the micro-analysis

The Head of the Laboratory was held responsible for organizing and conducting the microbiological testing.

The Head of the Laboratory organizes work on sampling, in accordance with the procedure.

Upon receipt of the sample for analysis microbiologists properly register it

Prepared culture media for the upcoming analysis according to the method of control.

Conduct research according to the methods of control.

Prior to analysis, or it is performed in parallel with control growth promotions of media, checking the suitability of the analytical procedure, if necessary, in accordance with the procedure.

If an unsatisfactory result of research, operating in accordance with procedure.

After conducting research analyst prepares an analytical report. Head of laboratory checks, sign it, and betray to the QC manager if the document includes the statement of QC manager.

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

Check Also

Procedure of the replacement procedure for the Purified Water Pump

To implement and procedure of the replacement procedure for the Purified Water Pump. This SOP …