Structural working in the physical-and-chemical laboratory

Structural working in the physical-and-chemical laboratory

OBJECTIVE 

• To lay down a procedure for the structural working in the physical-and-chemical laboratory.

 SCOPE 

• This SOP is applicable for organization of work in the physical-and-chemical laboratory.

RESPONSIBILITY 

• Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP.

 ACCOUNTABILITY 

• Quality Control and Head QA Head shall be accountable for compliance of this SOP.

ATTACHMENTS 

• Organizational structure            –            Attachment-I

PROCEDURE 

• The physical-and-chemical laboratory makes analyses for compliance of raw material, in-process products, and packaging material, finished products with specifications that were prepared during registration of the product.
• Laboratory staff education, training, technical knowledge and work experience meet the requirements for performing of the approved functions. There is no conflict of interests; the staff is interested in receiving qualitative results of analyses.
• The results of the analyses are to be authentic, reliable and accurate.
•  For good quality control system the laboratory has an appropriate organizational structure (Attachment I).
• The Lab. In charge is responsible for:
•  planning, organization, monitoring of the laboratory functioning; providing its compliance with Good Laboratory Practice, including preparation of quality control programs, creation of required quality guarantees and  safety engineering guarantees;
• carrying out of correction actions in case of receiving the results, which do not conform to the specifications.
•  To avoid suspension of testing the Lab. In charge plans the purchase of material resources (chemical reagents, laboratory glassware, reference standards, and instruments for analyses) beforehand. He/she controls the state of instruments; appoints the responsible persons for keeping reagents, precursors, operability and calibration of the instruments. He/she is responsible for organization and performing of the chemical-and-physical analysis; appoints the responsible persons for preparation and standardization of volumetric solutions, making analyses of raw and purified water.
•  Every group of the structure works in accordance with the job responsibilities specified by the QC Head; makes analyses in compliance with approved specifications and standard test procedures, prepares analytical reports in a proper manner. In case of controversial results each group informs the Lab. In charge. Each group keeps safety measures in the laboratory.
•  On receiving of GRN for RM/Analysis request for water the Lab. In charge organizes the sampling procedure . She/he also intimates the microbiological laboratory In charge for the sampling of the same.
• On receiving of In Process Analysis Requisition Sheet form along with samples of granules/ tablets/ capsules and liquid orals the Lab. In charge distributes the same along with the format for Analytical Report to the analyst. After the completion of analysis he/she checks the analytical report and Analysis Requisition Sheet, sends the same for approval to QC Head. QC Head approves and sends the copy of the documents to QA Head.
•  After receiving the raw material samples for analysis the Lab. In charge distributes the samples to the responsible analysts. After the completion of analysis he /she checks the analytical report and sends the same for approval to QC Head. QC Head cross-checks and approves the analytical reports.
• On receiving of GRN for packaging material the Lab. In charge organizes the sampling procedure
• After receiving the packaging material samples for analysis the Lab. In charge distributes the samples to the responsible analysts. After the completion of analysis he/she checks the analytical report and sends the same for approval to QC Head. QC Head cross-checks and approves the analytical reports.
• QC Head and Lab. In charge are responsible for Good Laboratory Practice and following of current specification and standard test procedures.
• Release of certificate of analysis:
• the Lab. In charge asks for the microbiological results from the microbiological laboratory In charge and generates the Certificate of Analysis from the analytical report of both Physical/Chemical and Microbiological;
• after generating the Certificate of Analysis the Lab. In charge forwards the same to QC Head for approval of the same;
•                 QC Head cross-checks and approves the Certificate of Analysis along with analytical reports.
•                 QC Head approves the Certificate of Analysis and makes the entries in the issuance log.
• The Lab. In charge is responsible for making the standard operating procedures, specification and standard test procedures. After making the documents the Lab. In charge forwards the same to QC Head for his approval. QA Head approves the same and makes them Master Copies and issues the Control Copies as per distribution list.
•  Laboratory staff is familiarized with the «Directive of Quality».

REFERENCES 

If any

ABBREVIATIONS

• SOP       :     Standard operating procedure
• QC        :      Quality Control Department
• QA       :       Quality Assurance department
• GRN      :     Goods Receipt Note
• RM   : Raw material

 DISTRIBUTUON LIST 

• Quality Assurance Department
• Quality Control Department

 HISTORY OF REVISION

  Attachment-I

Organizational structure

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