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What is a Deviation: A Deviation is a departure from standard procedures or specifications resulting in nonconforming material and/or processes or where there

have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety. For compliance to GMP and the sake of continuous improvement, these deviations are recorded in the form of Deviation Report (DR). Types of Deviations: 1. Following are some examples of deviations raised from different functional areas of business: 2. Production Deviation - usually raised during the manufacture of a batch production. 3. EHS Deviation - raised due to an environmental, health and safety hazards. 4. Quality Improvement Deviation - may be raised if a potential weakness has been identified and the implementation will require project approval. 5. Audit Deviation - raised to flag non-conformance identified during internal, external, supplier or corporate audits. 6. Customer Service Deviation - raised to track implementation measures related to customer complaints. 7. Technical Deviation - can be raised for validation discrepancies. For example: changes in Manufacturing Instruction. 8. Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials/components, packaging or imported finished goods. 9. System Routing Deviation - raised to track changes made to Bill of materials as a result of an Artwork change. When to Report Deviation: A Deviation should be raised when there is a deviation from methods or controls specified in manufacturing documents, material control documents, standard operating procedure for products and confirmed out of specification results and from the occurrence of an event and observation suggesting the existence of a real or potential quality related problems. A deviation should be reported if a trend is noticed that requires further investigation. All batch production deviations (planned or unintended) covering all manufacturing facilities, equipments, operations, distribution, procedures, systems and record keeping must be reported and investigated for corrective and preventative action. Reporting deviation is required regardless of final batch disposition. If a batch is rejected a deviation reporting is still required. Different Levels of Deviation Risks: For the ease of assessing risk any deviation can be classified into one of the three levels 1, 2 & 3 based on the magnitude and seriousness of a deviation. Level 1: Critical Deviation Deviation from Company Standards and/or current regulatory expectations that provide immediate and significant risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems Level 2: Serious Deviation Deviation from Company Standards and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety or data integrity or could potentially result in significant observations from a regulatory agency or a combination/repetition of "other" deficiencies that indicate a failure of system(s). Level 3: Standard Deviation Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction or suggestions given on how to improve systems or procedures that may be compliant but would benefit from improvement (e.g. incorrect data entry). How to Manage Reported Deviation: The department Manager or delegate should initiate the deviation report by using a standard deviation form as soon as a deviation is found. Write a short description of the

fact with a title in the table on the form and notify the Quality Assurance department within one business day to identify the investigation. QA has to evaluate the deviation and assess the potential impact to the product quality, validation and regulatory requirement. All completed deviation investigations are to be approved by QA Manager or delegate. QA Manger has to justify wither the deviation is a Critical, Serious or Standard in nature. For a deviation of either critical or serious nature QA delegate has to arrange a Cross Functional Investigation. For a standard type deviation a Cross functional Investigation (CFI) is not necessary. Immediate corrective actions have to be completed before the final disposition of a batch. Final batch disposition is the responsibility of Quality Assurance Department. If a critical or serious deviation leads to a CFI, corrective and preventive actions should be determined and follow up tasks should be assigned to area representatives. Follow up tasks should be completed within 30 business days of the observation of deviation. If a deviation with CFI can not be completed within 30 business days, an interim report should be generated detailing the reason for the delay and the progress so far. After successful completion of the Follow up tasks Deviation should be completed and attached with the Batch Report /Audit report/ Product complaint report /Safety investigation report as appropriate. What To Check During The Deviation Assessment: QA delegate has to conduct a primary Investigation on the deviation reported and evaluate the following information 1. Scope of the deviation - batch affected (both in-process and previously released) 2. Trends relating to (but limited to) similar products, materials, equipment and testing processes, product complaints, previous deviations, annual product reviews, and /or returned goods etc where appropriate. 3. A review of similar causes. 4. Potential quality impact. 5. Regulatory commitment impact. 6. Other batches potentially affected. 7. Market actions (i.e. recall etc)

Role of Quality Assurance 1.0 Purpose : To establish Quality Assurance System in the Organization.

2.0 Objective : To provide a documented procedure for establishment of Quality Assurance System in the Organization.

3.0 Scope : To provide the guidelines for the proper implementation of the Quality Assurance System.

4.0 Responsibility : All QA personal.

5.0 Procedure : Ensure all operations in Production / QC / Stores are performed in accordance with the relevant cGMP guidelines.

To accompany External audit personnel during inspections and prepare corrective action plan in conjunction with Production / QC / Stores and ensure implementation of corrective actions. To approve all master documents BMR, MFR, MSDS, Specifications, SOP, Validation Protocols and reports. Approve the artwork in co-ordination with Quality Control Department, Packaging Development Department and Production. To issue BMR each page having unique signature for authenticity. To review and control BMR and QC data for each batch of product and give final release before dispatch of the product. To ensure that no changes are made in formula, process with out information and approval from license holder/customer. In order to regularize change in equipment, facility, utility, packaging and analytical procedure, raise change control for approval. To co-ordinate all validation activities associated with production and QC i.e. process, equipment, utility, analytical method, testing equipments. To prepare schedule and perform Internal audits to ensure GMP compliance. Corrective Action Plan to be put in place for the observation and shall be filed. To register all customer complaint and co-ordinate investigation activities with QC / Production and to prepare final report. To provide relevant cGMP training to new entrants and retraining to all qualified production / quality control staff. To keep track of technical training schedule of Production / QC and keep detailed training file for all such activities. To handle all out of specifications results as per SOP. To ensure all relevant QA in process checks and line clearances are performed in day to day production activities. To review and check periodically: Maintenance schedules. Pest control schedules. Stability test results.

Inspection for self inspection program:


1.0 Purpose : To provide instruction for Self Inspection program. 2.0 Objective : To provide a documented procedure for Self Inspection program.

3.0

Scope

This procedure is applicable for self-inspection program.

4.0

Responsibility : Primary: Officer QA / Officer-Store Secondary: Officer QA Manager.

5.0

Procedure : Routine inspection A trained Quality Assurance person(s) takes routine visit to processing area for the monitoring of routine production activities. Following area / activities shall be covered in routine inspection.

Cleanliness of area / equipment / personnel etc. Identification on equipment/containers /rooms. Calibration of equipments /instruments. Processing area for processing activity. Filling Batch Manufacturing Records. Reference to design procedures, specification, and test procedures, standard operating procedure. Hygiene practices for handling of equipments /products. In case of any discrepancy observed note down the observations in book and take the initial of concerned area in-charge for acknowledge. In the case of major discrepancy inform to Quality Assurance Head and respective Department Head for immediate action.

Quality Assurance department in consultation with other concern department shall decide the course of action.

6.0

Scheduled for Audit Audit schedule shall be made by Quality Assurance Department concerned with other department Heads. Audit Team Audit team shall be made from local staff, expertise and knowledgeable in their field of activity and familiar with GMP. An expert from outside other than local staff but in the same organization familiar with the GMP requirements and expertise may be appointed. The team shall notify the auditors 10 days prior to audit to ensure routine work is well organized and planned. A member of the audit cannot audit his own area of activity. The audit team can call for all such relevant records, inspect sites, operation interact with people cutting across hierarchy to place factual position for management review and action. Audit team can break up in 2 or more team and carry out inspection separately. Department wise separate audit checklist shall be prepared. Findings and observation report in writing should be clear, unambiguous and with facts and reference. The approach of the self-audit team shall be such that information is willingly volunteered and open. Audit Frequency : Two Times in a Year. Audit Checklist. Separate audit checklist shall be made for each department, e.g. Production, Maintenance, Stores, and Quality Control. Inspection Report Audit report shall be made by QA with coordination of other team members. Audit report should mention. Audit observations. Suggestion for corrective action. Name of responsible personnel who will take the corrective action of respective department. The audit report shall be given to each of the section(s), concerning their activity the plant manager shall receive the copy. Discuss the findings with auditee or concerned department head. All the audit team members are required to revert with their audit report. In case major deviation observed in auditing a deviation analysis need to be conducted. A copy of deviation analysis report is submitted to plant Manager Submit the report to Quality Assurance. Quality Assurance to log the self-inspection report in sequential log. Co-ordinate with Dept. being audited for corrective and preventive action. Based on findings prepare summary of preventive and corrective action plan by Quality Assurance In-Charge. If preventive actions are of long term, appoint a person for the follow up of Preventive action. Review the results of preventive actions. Close the self-inspection report as per the closure checklist. Reference Document :

Audit schedule Audit team Audit Checklists (Production, Stores, Maintenance & QC) Audit report format

Audit compliances format Audit closure

Instruction for Vendor Approval / Qualification.


1.0 Purpose : To provide instruction for Vendor approval / qualification. 2.0 Objective : To provide a documented procedure for Vendor approval / qualification.

3.0

Scope

This procedure is applicable for Vendor approval / qualification.

4.0

Responsibility : Quality Control Quality Assurance Purchase Department

5.0

Procedure : Vendors of raw materials and packaging materials shall be categorized as below: Critical Vendors. All vendors who supply active raw materials, inactive raw materials, printed packaging materials, primary packaging materials are classified as critical vendors. Non-critical Vendors. Suppliers of materials, which do not have direct / impact on product quality. These vendors shall be classified as non-critical vendor and approval shall be based on routine compliances to the specifications. Ask the vendor to submit samples of three consecutive batches of the material for testing. Ask the vendor to fill and submit vendor / contract registration form for official record. Ask quality control department, to carry out testing and report the analytical findings to the material department. On satisfactory conformance with the specification, material department sends the supplier a questionnaire to the vendor in order to get aware of his systems and mode of working. Prepare a cross-functional audit that makes a visit to the vendors facility on a predetermined date and evaluate his facility. Teams prepare a vendor audit report with additional information like, GMP, WHO etc. certification and send to QA department. Upon receipt of the filled questionnaire, QA analyzes it and marks off the vendor to the approved vendor list upon satisfaction. The vendor certificate of analysis should contain, name and address of vendor, date of manufacturing and or retest / expiry date of the batch, test results along with specification, and authorized signature. The processing of new vendor of recipient should be critically monitored. Any adverse observation during the period of stability study shall be brought to notice immediately to production department, purchase department and quality assurance.

Vendors are evaluated as per followings:

The vendors are evaluated on the basis of quality of material and timely supply. Prepare evaluation report as a part of the trend analysis. In case any critical non-conformance observed during the periodical evaluation of vendor, which has an adverse effect of the quality of product, seizing the vendor in inventory system shall stop further procurement. Revalidation of the vendor to be performed in case of adverse effect (e.g. material failure) or after every two years for critical vendors on regular basis.

6.0

Reference Document :

Vendor registration form Vendor audit report Vendor

Annual Product Review of finished active pharmaceutical ingredient (APIs)


Purpose : To provide instruction for Annual Product Review of finished active pharmaceutical ingredient (APIs)

bjective : To provide a documented procedure for Annual Product Review of finished active pharmaceutical ingredient (APIs)

Scope :

This procedure is applicable to all Active Pharmaceutical Ingredients manufactured in QA department at -----Pharmaceuticals,
4.0 Responsibility : Manager QC / Manager Production / QA Manager.

5.0

Procedure : Total performance review of each finished active pharmaceutical ingredient (API) shall be carried out separately. An annual product review shall be written on yearly basis. An annual product review shall contain at least the following information: Quality Attributes with respect to: o o o o o o Assay trends Related substance trends Impurities profile Residual solvents. Summary of out of specification results Other critical product specific quality attributes.

Production with respect to: o o o No. of batches produced Product yield trends Investigation on yield deviations

Deviation occurred during normal operations, investigation report of deviations corresponding corrective and preventive actions taken. o Reprocessed or reworked batches

and

Stability Data: Market Complaint and Returns: Changes with respect to: o o o o o Standard testing procedures Specifications Standard operating procedures Process Equipment

o o o o

Changes in product label or Packaging configuration: Status on Process Validation: Product Distribution Data: The designated persons shall provide the relevant details to quality assurance for compilation.

The completed checklist as per attached annexure with necessary attachment shall be signed and dated by the person who prepared the report. The product review documents shall be reviewed by manager quality assurance and approved by Head-Q.A. The product review documents shall be preserved for 5 years with quality

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