Quality Control

Procedure to registrations samples, which enter on analysis in the microbiological laboratory

Procedure to registrations samples, which enter on analysis in the microbiological laboratory

To lay down the procedure to registrations samples, which enter on analysis in the microbiological laboratory.

This operation procedure is applicable for registration of samples, which enter for analysis in the microbiological laboratory.

PROCEDURE

New incoming material (samples of the finished product, raw materials, water, as well as the working environment) for analysis to a laboratory registered in the log book.

The log entry by a specialist of Microbiological laboratory only a ballpoint pen with blue ink.

In the log book shows the date the income and precise characterization of the sample: the title, series and number of the forthcoming analysis.

Samples are subjected to the day of admission, if the limit is not defined delay appropriate SOP.

Report appropriate form is filled in the course of analysis.

In the form of the report made findings at the end of the analysis . record a summary of the research methods, preconditioning and calculations made,  if any were made.

At the end of the analysis in the form of the report shall be made results.

The report is signed with the date by the analyst, who has made the analysis  and  Head of the laboratory then by Head of the quality control department,  if it is provided in the form of SOP.

Based on the findings outlined in the report fills the corresponding graphs of the log, the date of the results. Log entry confirmed by the signature analysis, performed the research and signed by Head of the laboratory.

If done wrong entry in the registration document, in report, or in logbook, then allowed a strikethrough line, the correct entry in the same or an adjacent graph with the date of the correction, and the signature of the specialist.

Correction can only analyst, who conduct analysis, or Head of the laboratory.

In the case when an error in the registration documentation was found by analyst, he or she must inform the Head of the laboratory.

ABBREVIATIONS

SOP: Standard operating procedure

QA: Quality Assurance department

TAMC: total aerobic microbial count

TYMC: total yeasts and moulds count

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 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, Panacea Biotec Ltd, and Nectar life Science 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