Physical-and-chemical test analysis analytical reports

Physical-and-chemical test analysis analytical reports

OBJECTIVE 

• To provide the procedure analytical reports/calculation sheet.

SCOPE 

• This SOP is applicable to the the procedure analytical reports/calculation sheet.

RESPONSIBILITY

• Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP.

ACCOUNTABILITY 

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

ATTACHMENTS 

• Analytical report/ Calculation sheet (Stage wise)                                                          – Attachment-I
• Analytical report/ Calculation sheet for Raw material                                                 – Attachment-II
• Analytical report/ Calculation sheet for packaging material                                      – Attachment-III

PROCEDURE 

• Analytical report is a printed authentic document for data recording (sample, procedure (as per specification), calculation, analysis results).
• After the test performing the results are entered in analytical report.
• Separate analytical report is used for every sample or sample set.
• Analytical report consists of:

– description of the sample (name, batch No., batch size etc.);

– sampling date;

– A. R. No.;

– specification No.;

– Mfg. date, Exp. date;

– information about preparation and usage of the reference standards, reagents and standard solutions;

– calculations (units of measurement, conversion factor etc.);

– analysis results and their compliance with the approved norms.

•  Product specific analytical reports/calculation sheets are prepared in MS-Excel (Attachment-I, Attachment-II), these sheets are product specific, validated for auto calculation of the results and linked with corresponding STP for calculation and results.
•   Product specific analytical reports / calculation sheets are selectively locked for data entry and provide electronic record safety and data entry level.
• Product specific analytical report / calculation sheets are locked for overwrite and prevent user to accidently save the edited sheet. Sheet opens in read only version and can be saved only in different name (for example: Product batch No.)
• Take printout of a specific analytical report / calculation sheet before starting the analysis. Record the data while performing the analysis, in a hard and soft copy of analytical report / calculation sheet.
• Sheet calculates the data and provides the results. Now record the final result calculated in the sheet in print version and save the working copy of calculation sheet with the name as «Batch No. of the product».
• For Packing material, Calculation sheet are prepared as base product specific (ex: Carton, Foil, Label etc.) due to its large quantity and dynamic changing requirements (Attachment-III).
• For Stability studies, Calculation sheet meant for FP analysis must be used and stating «NA» for those analysis, which are not required. (Attachment-I)
• For any additional analysis, which do not have specific analytical report / calculation sheet, blank format of electronic analytical report / calculation sheet also can be used.
• Instrument analysis data are attached to the analytical report (chromatograms, spectrograms, etc.)
• Analytical report must be readable and without mistakes
• The mistake is crossed out with one line, the new information is written beside. Do not overwrite the previous data.
•  Completed analytical report contains documented confirmation sample complies/ does not comply with the specifications.
• The analytical report is signed and dated by analysts, who made every analysis.
• The analytical report is checked by the QC lab In-Charge and sent to the QC Head for approval.
•  On the basis of the analytical reports (including microbiological analysis) the certificate of analysis (SOP) for raw material, finished products and packaging material is prepared; and purified/raw water analysis report is prepared.
• Documents are stored for 1 year more after expiry date.

REFERENCES 

• SOP

ABBREVIATIONS 

• SOP: Standard Operating Procedure
• QC: Quality Control Department
• QA: Quality Assurance Department

DISTRIBUTION LIST

• Quality Control Department
• Quality Assurance Department

HISTORY OF REVISION

Attachment-I

Analytical report/ Calculation sheet (Stage wise)  

Name of the sample:                                                              A. R. No.:

Batch No.:                                                                            Mfg. Date:

Date of sampling:                                                                Exp. Date:

CS issued by/Date:                                                          STP No.:

CS issued by/Date:                            Sheet No.:                                      STP No.:

Calculation sheet Reviewed By:

Date:

Attachment-II

Analytical report/ Calculation sheet for Raw material 

Name of the sample:                                                              A. R. No.:

Batch No.:                                                          Quantity                                  Mfg. Date:

Date of sampling:                                            Quantity sampled                     Exp. Date:

CS issued by/Date:                                                       STP No.:

CS issued by/Date:                            Sheet No.:                                      STP No.:

Calculation sheet Reviewed By:

Date:

Attachment-III

Analytical report/ Calculation sheet for packaging material 

Name of the sample:                                                              A. R. No.:

Batch No.:                                                                            Mfg. Date:

Date of sampling:                                                                Exp. Date:

CS issued by/Date:                                                          STP No.:

CS issued by/Date:                            Sheet No.:                                      STP No.:

Calculation sheet Reviewed By:

Date: